A Phase 4 interventional study of StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon in Peripheral Arterial Disease, sponsored by Spectranetics Corporation. Completed at 10 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by Spectranetics Corporation (part of Philips) · Phase 4, Interventional, and Treatment
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the StellarexTM 0.014" OTW Drug-coated Angioplasty Balloon in the treatment of lesions in "below the knee" popliteal (P3 segment) and infra-popliteal arteries according to the Instructions for Use in Rutherford-Becker Classification (RCC) 3, 4 and 5 patient populations. This study will be conducted in Europe across up to 10 centers in up to 75 subjects. Office visits will occur at 30 days, 6, 12, and 24 months post-index procedure.
There is a significant amount of evidence that the use of Paclitaxel-coated balloons in the treatment of peripheral arterial disease (PAD) has demonstrated favorable outcomes when used to treat lesions in the superficial femoral and popliteal arteries. For subjects with lesions in the infrapopliteal arteries, which includes lesions in the mid to distal popliteal artery and below, a smaller profile balloon is necessary. Typically, lesions in the SFA and proximal popliteal arteries are treated by larger diameter balloons and larger sized guidewires (most commonly 0.018" or 0.035") which are too large for vessels below-the-knee. For this reason, the Stellarex™ 0.014" OTW Drug-coated Angioplasty Balloon was developed as a line extension to the Stellarex™ 0.035" device in order to accommodate the treatment of these smaller vessels. The Stellarex™ 0.014" balloon has the same drug concentration and is manufactured using a similar method as the Stellarex™ 0.035" device. Additionally, the Stellarex™ 0.035" and 0.014" balloon share a common balloon diameter of 4 mm, a size which was used to treat lesions throughout the popliteal artery in the previous Stellarex 0.035" studies. For the reasons noted above, equivalence between the two devices has been demonstrated. Furthermore, it is believed that the 0.014" device will not demonstrate any performance differences nor change the anticipated or residual risks.
In conclusion, the current study has been developed in agreement with post-market requirements as per the Post Market Clinical Follow up (PMCF) plan. The prospective design of the study, the sample size and the selected outcomes will be able to provide the additional clinical information to support the safe use and performance of the Stellarex 0.014" device in the intended population of patients with below-the-knee arterial disease.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's enrollment of 49 is below the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Spectranetics Corporation is the lead sponsor of 19 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
First submitted after Spectranetics Corporation became part of Philips.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Previous or planned surgical or catheter-based procedure within 3 days before or 30 days after the index procedure. Note: This excludes successful inflow artery treatment within the same hospitalization or a documented preplanned minor amputation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
StellarexTM 0.014 OTW Drug-coated Angioplasty Balloon (Stellarex Balloon)
Combination Product: StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon
The Stellarex balloon (0.014") is indicated for the treatment of de-novo or re-stenotic lesions in the lower extremities to establish blood flow and to maintain vessel patency.
Primary Safety Endpoint-Composite Major Adverse Limb Events (MALE) + perioperative death (POD); the composite is the number of participants who do not have MALE or POD at 30 days
Major Adverse Limb Event (MALE) is defined as the composite of either major amputation or major re-intervention through 30 days of the index procedure. Major re-intervention is defined as creation of a new surgical bypass graft, the use of thrombectomy or thrombolysis or a major surgical graft revision such as a jump graft or an interposition graft. This is a single endpoint as it is a composite only subjects who do not have MALE or POD will be counted toward this endpoint MALE is defined as the composite of either major amputation or major re-intervention through 30 days of the index procedure. Major re-intervention is defined as creation of a new surgical bypass graft, the use of thrombectomy or thrombolysis or a major surgical graft revision such as a jump graft or an interposition graft. POD is all-cause death through 30 days of the index procedure.
Time frame: 30 days
Primary Performance Endpoint-Composite patency + limb salvage through 6 months; the composite is the number of participants with patency and limb salvage at 6 months
Patency defined as freedom from occluded target lesions (flow/no flow) verified by duplex ultrasound and clinically-driven target lesion revascularization (CD-TLR) Freedom from major amputation in the Target Limb This is a single endpoint as only subjects with both patency and limb salvage will be considered for this endpoint.
Time frame: 6 months
Major adverse event (MAE) rate at 6,12, and 24 months post index procedure
Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR
Time frame: 6 Months
Major adverse event (MAE) rate at 6,12, and 24 months post index procedure
Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR
Time frame: 12 months
Major adverse event (MAE) rate at 6,12, and 24 months post index procedure
Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR
Time frame: 24 months
Rate of CD-TLR at 6, 12 and 24 months
Rate of CD-TLR
Time frame: 6 months
Rate of CD-TLR at 6, 12 and 24 months
Rate of CD-TLR
Time frame: 12 months
Rate of CD-TLR at 6, 12 and 24 months
Rate of CD-TLR
Time frame: 24 months
Patency rate at 6, 12 and 24 months, defined as the presence of target lesion flow (absence of occlusion or no flow) as determined by Duplex Ultrasound (DUS) and freedom from CD-TLR
Patency rate
Time frame: 6 months
Patency rate at 6, 12 and 24 months, defined as the presence of target lesion flow (absence of occlusion or no flow) as determined by Duplex Ultrasound (DUS) and freedom from CD-TLR
Patency rate
Time frame: 12 months
Patency rate at 6, 12 and 24 months, defined as the presence of target lesion flow (absence of occlusion or no flow) as determined by Duplex Ultrasound (DUS) and freedom from CD-TLR
Patency rate
Time frame: 24 months
Rate of procedural complications defined as occurrence of all-cause death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, or thrombosis of target vessel through the end of the procedure
Rate of procedural complications
Time frame: through study completion, approximately 5 years
Rate of device or procedure related death at 30 days
Rate of device or procedure related death
Time frame: 30 days
Rate of major target limb amputation at 6 months post-procedure
Rate of major target limb amputation
Time frame: 6 months
Rate of major target limb amputation at 12 months post-procedure
Rate of major target limb amputation
Time frame: 12 months
Rate of major target limb amputation at 24 months post-procedure
Rate of major target limb amputation
Time frame: 24 months
Rate of clinically driven target vessel revascularization through 6 months
Rate of clinically driven target vessel revascularization
Time frame: 6 months
Rate of clinically driven target vessel revascularization through 12 months
Rate of clinically driven target vessel revascularization
Time frame: 12 months
Rate of clinically driven target vessel revascularization through 24 months
Rate of clinically driven target vessel revascularization
Time frame: 24 months
Lesion success:
Achievement of a final in-lesion residual diameter stenosis of \<50% (as determined by the angiographic core laboratory), using allowed pretreatment devices after guidewire passage through the lesion
Time frame: Through study completion, approximately 5 years
Technical success:
Achievement of a final in-lesion residual diameter stenosis of \<50% (as determined by the angiographic core laboratory), using the Stellarex 0.014" Drug-Coated Balloon without a device malfunction after a guidewire passage through the l
Time frame: Through study completion, approximately 5 years
Change in waveforms/TcPO2 from pre-procedure to 30 days
Change in waveforms/TcPO2 from pre-procedure
Time frame: 30 days
Change in waveforms/TcPO2 from pre-procedure to 6 months
Change in waveforms/TcPO2 from pre-procedure
Time frame: 6 months
Change in waveforms/TcPO2 from pre-procedure to 12 months
Change in waveforms/TcPO2 from pre-procedure
Time frame: 12 months
Change in waveforms/TcPO2 from pre-procedure to 24 months
Change in waveforms/TcPO2 from pre-procedure
Time frame: 24 months
Change in ankle-brachial index (ABI) from pre-procedure to 30 days
Change in ankle-brachial index (ABI) from pre-procedure
Time frame: 30 days
Change in ankle-brachial index (ABI) from pre-procedure to 6 months
Change in ankle-brachial index (ABI) from pre-procedure
Time frame: 6 months
Change in ankle-brachial index (ABI) from pre-procedure to 12 months
Change in ankle-brachial index (ABI) from pre-procedure
Time frame: 12 months
Change in ankle-brachial index (ABI) from pre-procedure to 24 months
Change in ankle-brachial index (ABI) from pre-procedure
Time frame: 24 months
Change in toe pressures (TP) from pre-procedure to 30 days
Change in toe pressures (TP) from pre-procedure
Time frame: 30 days
Change in toe pressures (TP) from pre-procedure to 6 months
Change in toe pressures (TP) from pre-procedure
Time frame: 6 months
Change in toe pressures (TP) from pre-procedure to 12 months
Change in toe pressures (TP) from pre-procedure
Time frame: 12 months
Change in toe pressures (TP) from pre-procedure to 24 months
Change in toe pressures (TP) from pre-procedure
Time frame: 24 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure to 30 days
Change in Rutherford-Becker Classification (RCC) from pre-procedure
Time frame: 30 days
Change in Rutherford-Becker Classification (RCC) from pre-procedure to 6 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure
Time frame: 6 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure to 12 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure
Time frame: 12 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure to 24 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure
Time frame: 24 months
Change in EQ-5D from pre-procedure to 30 days
Change in EQ-5D-5L (EuroQual-5 Dimension scale set and Visual Analog Scale score) from pre-procedure. Dimension score reporting will be determined at time of reporting and VAS score will be reported based on subject indicated scale from 0 to 100, where higher scores indicate positive outcome improvement.
Time frame: 30 days
Change in EQ-5D from pre-procedure to 6 months
Change in EQ-5D-5L (EuroQual-5 Dimension scale set and Visual Analog Scale score) from pre-procedure. Dimension score reporting will be determined at time of reporting and VAS score will be reported based on subject indicated scale from 0 to 100, where higher scores indicate positive outcome improvement.
Time frame: 6 months
Change in EQ-5D from pre-procedure to 12 months
Change in EQ-5D-5L (EuroQual-5 Dimension scale set and Visual Analog Scale score) from pre-procedure. Dimension score reporting will be determined at time of reporting and VAS score will be reported based on subject indicated scale from 0 to 100, where higher scores indicate positive outcome improvement.
Time frame: 12 months
Change in EQ-5D from pre-procedure to 24 months
Change in EQ-5D-5L (EuroQual-5 Dimension scale set and Visual Analog Scale score) from pre-procedure. Dimension score reporting will be determined at time of reporting and VAS score will be reported based on subject indicated scale from 0 to 100, where higher scores indicate positive outcome improvement.
Time frame: 24 months
In RCC 5 subjects, percentage of wounds healed from baseline to 30 days post-procedure as reported by the Investigator at the Investigative site
In RCC 5 subjects, percentage of wounds healed from baseline
Time frame: 30 days
In RCC 5 subjects, percentage of wounds healed from baseline to 6 months post-procedure as reported by the Investigator at the Investigative site
In RCC 5 subjects, percentage of wounds healed from baseline
Time frame: 6 months
In RCC 5 subjects, percentage of wounds healed from baseline to 12 months post-procedure as reported by the Investigator at the Investigative site
In RCC 5 subjects, percentage of wounds healed from baseline
Time frame: 12 months
Plan to share: No
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