CompletedNCT03421561Updated Feb 2, 2024Results posted

ILLUMENATE Pivotal Post-Approval Study (PAS)

An interventional study of Stellarex 0.035" OTW Drug-coated Angioplasty Balloon and EverCross™ 0.035 PTA Balloon Catheter in Peripheral Artery Disease, sponsored by Spectranetics Corporation. Completed at 41 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-02.

Sponsored by Spectranetics Corporation · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 300
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.

Read the detailed description

The objective of this continued follow-up of ILLUMENATE Pivotal Study subjects is to demonstrate the long term safety and effectiveness of the Stellarex DCB.

Each enrolled subject will be followed for 5 years (60 months) after treatment. A follow-up office visit will occur at 24 and 36 months. A follow-up telephone contact or an optional office visit will occur at 48 and 60 months.

Conditions studied

Peripheral Artery Disease

Browse trials for

Peripheral Arterial Disease 1,538

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria - From ILLUMENATE Pivotal IDE population TP-1397E

Study subjects must fulfill the following clinical criteria:

Symptomatic leg ischemia, requiring treatment of the superficial femoral artery (SFA) and/or popliteal artery.
Greater than or equal to 18 years of age.
Willing to provide written informed consent, and capable and willing to comply with all required follow-up evaluations within the defined follow-up visit windows.
Will not undergo other planned vascular interventions within 14 days before and/or 30 days after the protocol treatment (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).
Life expectancy >1 year.
Rutherford-Becker classification of 2, 3 or 4.
Study Subjects must fulfill the following angiographic criteria:
De novo or restenotic lesion (except for in-stent restenotic lesion) >70% within the SFA and/or popliteal artery in a single limb.
Single lesion which is ≥3 cm and ≤18cm in length (by visual estimation). NOTE: Tandem lesions can be treated. A tandem lesion is defined as two distinct lesions with 3 cm or less of healthy vessel separating the two diseased areas. The total cumulative length of the tandem lesions, including the healthy vessel, must not exceed 18 cm.
Lesion is treatable by no more than two (2) study devices.
Successful wire crossing of the lesion. The guidewire advancement should not be indicative of the presence of fresh thrombus in the lesion.
Target reference vessel diameter is ≥4 mm and ≤6 mm (by visual estimation).
Inflow artery is patent, free from significant lesion stenosis (≥50% stenosis is considered significant) as confirmed by angiography. Treatment of a target lesion is acceptable after successful treatment of inflow artery lesion(s). NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis \<30% without death or major vascular complication.
Target limb with at least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior magnetic resonance (MR) angiography or computed tomography (CT) angiography (within 45 days prior to index procedure). NOTE: treatment of outflow disease is NOT permitted.

Exclusion Criteria -

Subject with any of the following clinical criteria should be excluded:

Females who are pregnant, lactating, or intend to become pregnant, or males who intend to father children during study participation.
Known aortic aneurysm(s) > 5 cm.
Contraindication to dual anti-platelet therapy.
Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
Current participation in an investigational drug or another device study.
History of hemorrhagic stroke within 3 months.
Previous or planned surgical or interventional procedure within 14 days before or 30 days after the index procedure (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).
Prior endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. stents/stent grafts, cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure, or any previous placement of a bypass graft proximal to the target lesion.
Treatment of lesions in the contralateral limb with the CVI Paclitaxel-coated PTA Catheter.
Use of the CVI Paclitaxel-coated PTA Catheter in other than a single treatment session.
Chronic renal insufficiency (dialysis dependent, or serum creatinine >2.5 mg/dL within 30 days of index procedure).
Subject with any of the following angiographic criteria should be excluded:
Significant contralateral or ipsilateral common femoral disease that requires intervention during the index procedure.
No normal proximal arterial segment of the target vessel in which duplex ultrasound velocity ratios can be measured.
Known inadequate distal outflow.
Acute or sub-acute thrombus in the target vessel.
Aneurysmal target vessel.
Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy) during the index procedure in the target lesion or target vessel.
Treatment of the contralateral limb during the same procedure or within 30 days following the study procedure (exclusive of the iliac arteries which can be treated prior to enrollment).
Presence of concentric calcification that precludes PTA pre-dilation.
Prior stent placement in the target vessel.
Residual stenosis of greater than 70%, stent placement or flow-limiting (Grade D or greater) dissection following pre-dilation.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 300 participants (actual)

Study arms

Experimental
DCB Subjects
The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
Device: Stellarex 0.035" OTW Drug-coated Angioplasty Balloon
Placebo comparator
PTA Subjects
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.
Device: EverCross™ 0.035 PTA Balloon Catheter

Interventions

DeviceStellarex 0.035" OTW Drug-coated Angioplasty Balloon
The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
DeviceEverCross™ 0.035 PTA Balloon Catheter
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).

What researchers measure

Primary outcomes

Number of Participants With Target Vessel Patency at 24 Months Post-procedure
Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.
Time frame: 24 months post-procedure
Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure
The primary safety outcome is defined as freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days).
Time frame: 24 months post-procedure

Secondary outcomes

Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 24 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time frame: 24 months post-procedure
Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 36 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time frame: 36 months post-procedure
Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 48 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time frame: 48 months post-procedure
Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time frame: 60 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Time frame: 24 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Time frame: 36 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Time frame: 48 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Time frame: 60 months post-procedure
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Time frame: 24 months post-procedure
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Time frame: 36 months post-procedure
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Time frame: 48 months post-procedure
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Time frame: 60 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occuring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Time frame: 24 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Time frame: 36 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Time frame: 48 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Time frame: 60 months post-procedure
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Time frame: 24 months post-procedure
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Time frame: 36 months post-procedure
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Time frame: 48 months post-procedure
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Time frame: 60 months post-procedure
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Time frame: 24 months post-procedure
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Time frame: 36 months post-procedure
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Time frame: 48 months post-procedure
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Time frame: 60 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Time frame: 24 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Time frame: 36 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Time frame: 48 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Time frame: 60 months post-procedure
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR
Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR
Time frame: 24 months post-procedure
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR
Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR
Time frame: 36 months post-procedure
Change in Ankle-brachial Index (ABI) From Pre-procedure
The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.
Time frame: 24 months post-procedure
Change in Ankle-brachial Index (ABI) From Pre-procedure
The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.
Time frame: 36 months post-procedure
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication
Time frame: 24 months post-procedure
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication
Time frame: 36 months post-procedure
Change in Walking Distance From Pre-procedure
Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 24 month office visit.
Time frame: 24 months post-procedure
Change in Walking Distance From Pre-procedure
Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 36 month office visit.
Time frame: 36 months post-procedure
Change in Rutherford-Becker Classification From Pre-procedure
Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4\*-Ischemic rest pain 5\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \*Categories 4, 5, and 6 are also described as critical limb ischemia.
Time frame: 24 months post-procedure
Change in Rutherford-Becker Classification From Pre-procedure
Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4\*-Ischemic rest pain 5\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \*Categories 4, 5, and 6 are also described as critical limb ischemia.
Time frame: 36 months post-procedure
Change in EQ-5D Index From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.
Time frame: 24 months post-procedure
Change in EQ-5D Index From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.
Time frame: 36 months post-procedure
Change in EQ-5D VAS From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion
Time frame: 24 months post procedure
Change in EQ-5D VAS From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion
Time frame: 36 month post procedure

Results

Posted Feb 2, 2024

Participant flow

Participant flow — Overall Study
Milestone	DCB Subjects	PTA Subjects
Started	200	100
Completed	135	70
Not completed	65	30

Outcome measures

PrimaryNumber of Participants With Target Vessel Patency at 24 Months Post-procedure

Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Number of Participants With Target Vessel Patency at 24 Months Post-procedure
Participants	DCB Subjects	PTA Subjects
Number of Participants With Target Vessel Patency at 24 Months Post-procedure	88	45

PrimaryNumber of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure

The primary safety outcome is defined as freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days).

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure
Participants	DCB Subjects	PTA Subjects
Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure	142	73

SecondaryMajor Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)

Major adverse event (MAE) rate at 24 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Participants	DCB Subjects	PTA Subjects
Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)	34	22

SecondaryMajor Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)

Major adverse event (MAE) rate at 36 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Time frame:: 36 months post-procedure
Reported as:: Count of participants · Participants

Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Participants	DCB Subjects	PTA Subjects
Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)	46	27

SecondaryMajor Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)

Major adverse event (MAE) rate at 48 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Time frame:: 48 months post-procedure
Reported as:: Count of participants · Participants

Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Participants	DCB Subjects	PTA Subjects
Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)	55	33

SecondaryMajor Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)

Major adverse event (MAE) rate at 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Time frame:: 60 months post-procedure
Reported as:: Count of participants · Participants

Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Participants	DCB Subjects	PTA Subjects
Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)	64	37

SecondaryRate of Clinically-driven Target Lesion Revascularization

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Rate of Clinically-driven Target Lesion Revascularization
Participants	DCB Subjects	PTA Subjects
Rate of Clinically-driven Target Lesion Revascularization	29	19

SecondaryRate of Clinically-driven Target Lesion Revascularization

Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.

Time frame:: 36 months post-procedure
Reported as:: Count of participants · Participants

Rate of Clinically-driven Target Lesion Revascularization
Participants	DCB Subjects	PTA Subjects
Rate of Clinically-driven Target Lesion Revascularization	38	24

SecondaryRate of Clinically-driven Target Lesion Revascularization

Time frame:: 48 months post-procedure
Reported as:: Count of participants · Participants

Rate of Clinically-driven Target Lesion Revascularization
Participants	DCB Subjects	PTA Subjects
Rate of Clinically-driven Target Lesion Revascularization	44	28

SecondaryRate of Clinically-driven Target Lesion Revascularization

Time frame:: 60 months post-procedure
Reported as:: Count of participants · Participants

Rate of Clinically-driven Target Lesion Revascularization
Participants	DCB Subjects	PTA Subjects
Rate of Clinically-driven Target Lesion Revascularization	51	29

SecondaryRate of Target Lesion Revascularization

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Rate of Target Lesion Revascularization
Participants	DCB Subjects	PTA Subjects
Rate of Target Lesion Revascularization	32	20

SecondaryRate of Target Lesion Revascularization

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee

Time frame:: 36 months post-procedure
Reported as:: Count of participants · Participants

Rate of Target Lesion Revascularization
Participants	DCB Subjects	PTA Subjects
Rate of Target Lesion Revascularization	42	25

SecondaryRate of Target Lesion Revascularization

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee

Time frame:: 48 months post-procedure
Reported as:: Count of participants · Participants

Rate of Target Lesion Revascularization
Participants	DCB Subjects	PTA Subjects
Rate of Target Lesion Revascularization	48	29

SecondaryRate of Target Lesion Revascularization

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee

Time frame:: 60 months post-procedure
Reported as:: Count of participants · Participants

Rate of Target Lesion Revascularization
Participants	DCB Subjects	PTA Subjects
Rate of Target Lesion Revascularization	55	30

SecondaryRate of Clinically-driven Target Vessel Revascularization

Lesion revascularization occuring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Rate of Clinically-driven Target Vessel Revascularization
Participants	DCB Subjects	PTA Subjects
Rate of Clinically-driven Target Vessel Revascularization	1	1

SecondaryRate of Clinically-driven Target Vessel Revascularization

Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.

Time frame:: 36 months post-procedure
Reported as:: Count of participants · Participants

Rate of Clinically-driven Target Vessel Revascularization
Participants	DCB Subjects	PTA Subjects
Rate of Clinically-driven Target Vessel Revascularization	3	1

SecondaryRate of Clinically-driven Target Vessel Revascularization

Time frame:: 48 months post-procedure
Reported as:: Count of participants · Participants

Rate of Clinically-driven Target Vessel Revascularization
Participants	DCB Subjects	PTA Subjects
Rate of Clinically-driven Target Vessel Revascularization	3	2

SecondaryRate of Clinically-driven Target Vessel Revascularization

Time frame:: 60 months post-procedure
Reported as:: Count of participants · Participants

Rate of Clinically-driven Target Vessel Revascularization
Participants	DCB Subjects	PTA Subjects
Rate of Clinically-driven Target Vessel Revascularization	3	2

SecondaryRate of Target Limb Major Amputation

Number of subjects in which a major amputation occurred in the target limb

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Rate of Target Limb Major Amputation
Participants	DCB Subjects	PTA Subjects
Rate of Target Limb Major Amputation	1	0

SecondaryRate of Target Limb Major Amputation

Number of subjects in which a major amputation occurred in the target limb

Time frame:: 36 months post-procedure
Reported as:: Count of participants · Participants

Rate of Target Limb Major Amputation
Participants	DCB Subjects	PTA Subjects
Rate of Target Limb Major Amputation	1	0

SecondaryRate of Target Limb Major Amputation

Number of subjects in which a major amputation occurred in the target limb

Time frame:: 48 months post-procedure
Reported as:: Count of participants · Participants

Rate of Target Limb Major Amputation
Participants	DCB Subjects	PTA Subjects
Rate of Target Limb Major Amputation	2	0

SecondaryRate of Target Limb Major Amputation

Number of subjects in which a major amputation occurred in the target limb

Time frame:: 60 months post-procedure
Reported as:: Count of participants · Participants

Rate of Target Limb Major Amputation
Participants	DCB Subjects	PTA Subjects
Rate of Target Limb Major Amputation	2	0

SecondaryMortality Rate

Number of subject who have died during the post-procedure follow up period

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Mortality Rate
Participants	DCB Subjects	PTA Subjects
Mortality Rate	13	8

SecondaryMortality Rate

Number of subject who have died during the post-procedure follow up period

Time frame:: 36 months post-procedure
Reported as:: Count of participants · Participants

Mortality Rate
Participants	DCB Subjects	PTA Subjects
Mortality Rate	18	10

SecondaryMortality Rate

Number of subject who have died during the post-procedure follow up period

Time frame:: 48 months post-procedure
Reported as:: Count of participants · Participants

Mortality Rate
Participants	DCB Subjects	PTA Subjects
Mortality Rate	27	14

SecondaryMortality Rate

Number of subject who have died during the post-procedure follow up period

Time frame:: 60 months post-procedure
Reported as:: Count of participants · Participants

Mortality Rate
Participants	DCB Subjects	PTA Subjects
Mortality Rate	34	19

SecondaryRate of Occurrence of Arterial Thrombosis of the Treated Segment

Rate of occurrence of arterial thrombosis of the treated segment

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Participants	DCB Subjects	PTA Subjects
Rate of Occurrence of Arterial Thrombosis of the Treated Segment	3	0

SecondaryRate of Occurrence of Arterial Thrombosis of the Treated Segment

Rate of occurrence of arterial thrombosis of the treated segment

Time frame:: 36 months post-procedure
Reported as:: Count of participants · Participants

Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Participants	DCB Subjects	PTA Subjects
Rate of Occurrence of Arterial Thrombosis of the Treated Segment	4	0

SecondaryRate of Occurrence of Arterial Thrombosis of the Treated Segment

Rate of occurrence of arterial thrombosis of the treated segment

Time frame:: 48 months post-procedure
Reported as:: Count of participants · Participants

Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Participants	DCB Subjects	PTA Subjects
Rate of Occurrence of Arterial Thrombosis of the Treated Segment	4	0

SecondaryRate of Occurrence of Arterial Thrombosis of the Treated Segment

Rate of occurrence of arterial thrombosis of the treated segment

Time frame:: 60 months post-procedure
Reported as:: Count of participants · Participants

Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Participants	DCB Subjects	PTA Subjects
Rate of Occurrence of Arterial Thrombosis of the Treated Segment	4	0

SecondaryPatency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR

Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR
Participants	DCB Subjects	PTA Subjects
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR	88	45

SecondaryPatency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR

Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR

Time frame:: 36 months post-procedure
Reported as:: Count of participants · Participants

Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR
Participants	DCB Subjects	PTA Subjects
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR	65	35

SecondaryChange in Ankle-brachial Index (ABI) From Pre-procedure

The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Change in Ankle-brachial Index (ABI) From Pre-procedure
Participants	DCB Subjects	PTA Subjects
Improved	102	56
No Change	0	1
Worsened	39	22

SecondaryChange in Ankle-brachial Index (ABI) From Pre-procedure

Time frame:: 36 months post-procedure
Reported as:: Count of participants · Participants

Change in Ankle-brachial Index (ABI) From Pre-procedure
Participants	DCB Subjects	PTA Subjects
Improved	89	46
Worsened	31	23

SecondaryChange in Walking Impairment Questionnaire (WIQ) From Pre-procedure

A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
Participants	DCB Subjects	PTA Subjects
Improved	114	63
Worsened	39	19

SecondaryChange in Walking Impairment Questionnaire (WIQ) From Pre-procedure

Time frame:: 36 months post-procedure
Reported as:: Count of participants · Participants

Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
Participants	DCB Subjects	PTA Subjects
Improved	98	50
No Change	1	0
Worsened	32	24

SecondaryChange in Walking Distance From Pre-procedure

Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 24 month office visit.

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Change in Walking Distance From Pre-procedure
Participants	DCB Subjects	PTA Subjects
Improved	92	57
No Change	1	1
Worsened	49	22

SecondaryChange in Walking Distance From Pre-procedure

Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 36 month office visit.

Time frame:: 36 months post-procedure
Reported as:: Count of participants · Participants

Change in Walking Distance From Pre-procedure
Participants	DCB Subjects	PTA Subjects
Improved	77	47
No Change	2	0
Worsened	35	22

SecondaryChange in Rutherford-Becker Classification From Pre-procedure

Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4\*-Ischemic rest pain 5\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \*Categories 4, 5, and 6 are also described as critical limb ischemia.

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Change in Rutherford-Becker Classification From Pre-procedure
Participants	DCB Subjects	PTA Subjects
Improved	128	74
No Change	17	5
Worsened	8	3

SecondaryChange in Rutherford-Becker Classification From Pre-procedure

Time frame:: 36 months post-procedure
Reported as:: Count of participants · Participants

Change in Rutherford-Becker Classification From Pre-procedure
Participants	DCB Subjects	PTA Subjects
Improved	108	63
No Change	15	11
Worsened	7	2

SecondaryChange in EQ-5D Index From Pre-procedure

EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.

Time frame:: 24 months post-procedure
Reported as:: Count of participants · Participants

Change in EQ-5D Index From Pre-procedure
Participants	DCB Subjects	PTA Subjects
Improved	62	37
No Change	9	7
Worsened	32	15

SecondaryChange in EQ-5D Index From Pre-procedure

EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.

Time frame:: 36 months post-procedure
Reported as:: Count of participants · Participants

Change in EQ-5D Index From Pre-procedure
Participants	DCB Subjects	PTA Subjects
Improved	52	35
No Change	15	6
Worsened	28	15

SecondaryChange in EQ-5D VAS From Pre-procedure

EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion

Time frame:: 24 months post procedure
Reported as:: Count of participants · Participants

Change in EQ-5D VAS From Pre-procedure
Participants	DCB Subjects	PTA Subjects
Improved	52	30
No Change	12	10
Worsened	40	19

SecondaryChange in EQ-5D VAS From Pre-procedure

EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion

Time frame:: 36 month post procedure
Reported as:: Count of participants · Participants

Change in EQ-5D VAS From Pre-procedure
Participants	DCB Subjects	PTA Subjects
Improved	53	26
No Change	6	9
Worsened	36	21

Adverse events

Collected over Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
DCB Subjects	34/200 (17%)	177/200 (88.5%)	192/200 (96%)
PTA Subjects	19/100 (19%)	85/100 (85%)	95/100 (95%)

Most frequent serious events

Showing 10 of 345

Most frequent serious events
Event	DCB Subjects	PTA Subjects
PERIPHERAL ARTERY STENOSISVascular disorders	45/200	27/100
INTERMITTENT CLAUDICATIONVascular disorders	43/200	18/100
PERIPHERAL ARTERY RESTENOSISInjury, poisoning and procedural complications	24/200	13/100
Chest PainGeneral disorders	20/200	8/100
PneumoniaInfections and infestations	14/200	9/100
FEMORAL ARTERY DISSECTIONVascular disorders	17/200	6/100
RENAL FAILURE ACUTERenal and urinary disorders	14/200	3/100
Atrial FibrillationCardiac disorders	8/200	6/100
Cardiac Failure CongestiveCardiac disorders	12/200	5/100
Coronary Artery DiseaseCardiac disorders	12/200	4/100

Most frequent other events

Showing 10 of 39

Most frequent other events
Event	DCB Subjects	PTA Subjects
INTERMITTENT CLAUDICATIONVascular disorders	74/200	35/100
PERIPHERAL ARTERY STENOSISVascular disorders	54/200	34/100
PAIN IN EXTREMITYMusculoskeletal and connective tissue disorders	48/200	21/100
PERIPHERAL ARTERY RESTENOSISInjury, poisoning and procedural complications	30/200	18/100
CHEST PAINGeneral disorders	35/200	17/100
ARTHRALGIAMusculoskeletal and connective tissue disorders	20/200	15/100
DYSPNOEARespiratory, thoracic and mediastinal disorders	29/200	11/100
Atrial FibrillationCardiac disorders	12/200	11/100
OEDEMA PERIPHERALGeneral disorders	13/200	11/100
LOCAL SWELLINGGeneral disorders	7/200	10/100

Baseline characteristics

Age, Continuous
Age, Continuous(years)	DCB Subjects	PTA Subjects	Total
Mean	68.3 ± 10.3	69.8 ± 9.8	68.8 ± 10.2

Sex: Female, Male
Sex: Female, Male(Participants)	DCB Subjects	PTA Subjects	Total
Female	88	36	124
Male	112	64	176

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	DCB Subjects	PTA Subjects	Total
Hispanic or Latino	27	11	38
Not Hispanic or Latino	152	77	229
Unknown or Not Reported	21	12	33

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	DCB Subjects	PTA Subjects	Total
American Indian or Alaska Native	2	0	2
Asian	2	1	3
Native Hawaiian or Other Pacific Islander	NA	NA	NA
Black or African American	35	19	54
White	142	68	210
More than one race	NA	NA	NA
Unknown or Not Reported	19	12	31

Region of Enrollment
Region of Enrollment(participants)	DCB Subjects	PTA Subjects	Total
Austria	17	10	27
United States	183	90	273

Body Mass Index
Body Mass Index(kg/m^2)	DCB Subjects	PTA Subjects	Total
Mean	29.0 ± 6.1	28.8 ± 5.6	29.0 ± 6.0

Ankle-Brachial Index
Ankle-Brachial Index(ratio)	DCB Subjects	PTA Subjects	Total
Ankle-Brachial Index Measurement	0.75 ± 0.21	0.76 ± 0.20	0.75 ± 0.21
Non-Compressible	NA ± NA	—	NA ± NA

Rutherford-Becker Clinical Category
Rutherford-Becker Clinical Category(Participants)	DCB Subjects	PTA Subjects	Total
RCC 2	63	35	98
RCC 3	129	60	189
RCC 4	8	5	13

18 further baseline measures are reported on the registry.

Study locations

41 sites

Yuma Regional Medical Center
Yuma, Arizona 85364, United States
Mission Cardiovascular Research Institute
Fremont, California 94538, United States
Good Samaritan Hospital - Los Angeles
Los Angeles, California 90017, United States
Medical Center of the Rockies
Loveland, Colorado 80538, United States
Yale University School of Medicine
New Haven, Connecticut 06510, United States
Cardiovascular Research of North Florida
Gainesville, Florida 32605, United States
Baptist Cardiac and Vascular Institute
Miami, Florida 33176, United States
Coastal Vascular and Interventional
Pensacola, Florida 32504, United States
Emory University Hospital
Atlanta, Georgia 30322, United States
Northside Hospital
Atlanta, Georgia 30342, United States
Advocate Health and Hospitals Corporation
Oakbrook Terrace, Illinois 60181, United States
St. Joseph Hospital
Fort Wayne, Indiana 46802, United States
Central Iowa Hospital Corporation
Des Moines, Iowa 50309, United States
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan 49770, United States
Metro Health Hospital
Wyoming, Michigan 15146, United States
Jackson Heart Clinic
Jackson, Mississippi 39216, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey 08015, United States
Mount Sinai Medical Center
New York, New York 10029, United States
Mission Hospital
Asheville, North Carolina 28801, United States
Wake Heart Research
Raleigh, North Carolina 19010, United States
Rex Hospital
Raleigh, North Carolina 27607, United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195, United States
OhioHealth Research Institute
Columbus, Ohio 43214, United States
North Ohio Research LTD.
Elyria, Ohio 44035, United States
Jobst Vascular Institute
Toledo, Ohio 43606, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma 73120, United States
Heritage Valley Health System
Beaver, Pennsylvania 15009, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232, United States
Pinnacle Health Cardiovascular Institute, INC.
Wormleysburg, Pennsylvania 17043, United States
Sanford Health Vascular Associates
Sioux Falls, South Dakota 57117, United States
University Surgical Associates
Chattanooga, Tennessee 37403, United States
Wellmont Holston Valley Medical
Kingsport, Tennessee 37660, United States
Premier Surgical Associates
Knoxville, Tennessee 37909, United States
Texas Health & Research Education Institution
Dallas, Texas 75231, United States
El Paso Cardiology Associates
El Paso, Texas 79902, United States
University of Texas Health Science Center - Houston
Houston, Texas 77030, United States
University of Virginia
Charlottesville, Virginia 22908, United States
CAMC Clinical Trial Center
Charleston, West Virginia 25304, United States
Aurora Health Care
Milwaukee, Wisconsin 53215, United States
Medical University Graz
Graz, Austria
Hanusch Krankenhaus Wien
Vienna, Austria

References and documents

Publications

Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30. PubMed 31567024 ↗

Study documents

Study protocol · Apr 14, 2017
Statistical analysis plan · Sep 1, 2016

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT03421561
Lead sponsor: Spectranetics Corporation
Responsible party: Sponsor
First posted: Feb 5, 2018
Start date: Jun 18, 2013
Primary completion: Dec 8, 2017
Completion: Oct 6, 2020
Results posted: Feb 2, 2024
Last update: Feb 2, 2024

Study contacts

Sean Lyden, MD

principal investigator · The Cleveland Clinic

Prakash Krishnan, MD

principal investigator · Mount Sinai Health System

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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