CompletedNCT01858363EU RCTUpdated Oct 13, 2021Results posted

ILLUMENATE EU Randomized Clinical Trial

An interventional study of CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter and Bare Percutaneous Transluminal Angioplasty Balloon Catheter in Peripheral Arterial Disease and Claudication, sponsored by Spectranetics Corporation. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-13.

Sponsored by Spectranetics Corporation (part of Philips) · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 294
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.

Conditions studied

Peripheral Arterial Disease
Claudication

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Keywords

Peripheral arterial disease
claudication
drug-coated balloon
drug-eluting balloon

In context

Peripheral 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 294 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

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 before Spectranetics Corporation became part of Philips.

Browse Spectranetics Corporation studies →All Philips studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

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

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.

Inclusion criteria

Symptomatic leg ischemia requiring treatment of the superficial femoral or popliteal arteries
Rutherford clinical category 2, 3 or 4
Male or non-pregnant female at least 18 years

Exclusion criteria

Exclusion Criteria:

Co-existing aneurismal disease of the abdominal aorta, iliac or popliteal arteries
Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti- therapy
Known intolerance of study medications, paclitaxel or contrast agent
Active participation in another device or drug study

Terms in these criteria, in plain language(3)

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 294 participants (actual)

Study arms

Experimental
Paclitaxel-coated balloon
Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.
Device: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Placebo comparator
Bare balloon
Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.
Device: Bare Percutaneous Transluminal Angioplasty Balloon Catheter

Interventions

DeviceCVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
DeviceBare Percutaneous Transluminal Angioplasty Balloon Catheter

What researchers measure

Primary outcomes

Patency at 12-months
The primary efficacy endpoint was patency at 12 months post-procedure defined as the absence of target lesion restenosis determined by duplex ultrasound peak systolic velocity ratio (PSVR) ≤2.5 and freedom from clinically-driven target lesion revascularization (CD-TLR).
Time frame: 12 months
Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month
The primary safety endpoint was 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 12 months post-procedure.
Time frame: 30-Days and 12-Months

Results

Posted Oct 13, 2021

Participant flow

Participant flow — Overall Study
Milestone	Paclitaxel-coated Balloon	Bare Balloon
Started	222	72
Pre-discharge visit	219	72
1-month visit	214	68
6-month visit	208	64
12-month vist	205	61
24-month visit	184	58
36-month visit	169	53
48-month visit	157	53
Completed	146	46
Not completed	76	26
Withdrew: Death	35	9
Withdrew: Withdrawal by subject	28	14
Withdrew: Lost to follow-up	13	3

Outcome measures

PrimaryPatency at 12-months

The primary efficacy endpoint was patency at 12 months post-procedure defined as the absence of target lesion restenosis determined by duplex ultrasound peak systolic velocity ratio (PSVR) ≤2.5 and freedom from clinically-driven target lesion revascularization (CD-TLR).

Time frame:: 12 months
Reported as:: Number · percentage of lesions

Patency at 12-months
percentage of lesions	Paclitaxel-coated Balloon	Bare Balloon
Patency at 12-months	83.9 (78.5 to 88.5)	60.6 (47.8 to 72.4)

PrimaryPercentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month

The primary safety endpoint was 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 12 months post-procedure.

Time frame:: 30-Days and 12-Months
Reported as:: Number · percentage of participants

Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month
percentage of participants	Paclitaxel-coated Balloon	Bare Balloon
Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month	94.1 (90.0 to 96.9)	83.3 (71.5 to 91.7)

Adverse events

Collected over The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Paclitaxel-coated Balloon	35/219 (16%)	118/219 (53.9%)	180/219 (82.2%)
Bare Balloon	9/68 (13.2%)	38/68 (55.9%)	51/68 (75%)

Most frequent serious events

Showing 10 of 147

Most frequent serious events
Event	Paclitaxel-coated Balloon	Bare Balloon
PERIPHERAL ARTERY RESTENOSISInjury, poisoning and procedural complications	6/219	12/68
FEMORAL ARTERY DISSECTIONVascular disorders	17/219	6/68
PERIPHERAL ARTERY STENOSISVascular disorders	15/219	6/68
CORONARY ARTERY DISEASECardiac disorders	9/219	0/68
PANCREATITIS CHRONICGastrointestinal disorders	0/219	2/68
FEMUR FRACTUREInjury, poisoning and procedural complications	0/219	2/68
RADIUS FRACTUREInjury, poisoning and procedural complications	0/219	2/68
VASCULAR PSEUDOANEURYSMInjury, poisoning and procedural complications	3/219	2/68
CAROTID ARTERY STENOSISNervous system disorders	6/219	0/68
CATHETER SITE HAEMORRHAGEGeneral disorders	5/219	0/68

Most frequent other events

Showing 10 of 260

Most frequent other events
Event	Paclitaxel-coated Balloon	Bare Balloon
PERIPHERAL ARTERY RESTENOSISInjury, poisoning and procedural complications	20/219	15/68
PERIPHERAL ARTERY STENOSISVascular disorders	21/219	9/68
FEMORAL ARTERY DISSECTIONVascular disorders	21/219	7/68
ARTHRALGIAMusculoskeletal and connective tissue disorders	14/219	5/68
INTERMITTENT CLAUDICATIONVascular disorders	15/219	3/68
PAIN IN EXTREMITYMusculoskeletal and connective tissue disorders	14/219	4/68
CORONARY ARTERY DISEASECardiac disorders	10/219	0/68
BACK PAINMusculoskeletal and connective tissue disorders	10/219	0/68
PERIPHERAL ARTERIAL REOCCLUSIONInjury, poisoning and procedural complications	4/219	3/68
VASCULAR PSEUDOANEURYSMInjury, poisoning and procedural complications	4/219	3/68

Baseline characteristics

The Baseline Participants are based on the Intent-to-Treat (ITT) analysis set. The safety data for the adverse events section will be based on the Safety Set which has 219 participants in the Paclitaxel-coated arm and 68 in the Bare balloon arm.

Age, Continuous
Age, Continuous(years)	Paclitaxel-coated Balloon	Bare Balloon	Total
Mean	66.8 ± 9.2	69.0 ± 8.6	67.3 ± 9.1

Sex: Female, Male
Sex: Female, Male(Participants)	Paclitaxel-coated Balloon	Bare Balloon	Total
Female	62	23	85
Male	160	49	209

Rutherford Clinical Category
Rutherford Clinical Category(Participants)	Paclitaxel-coated Balloon	Bare Balloon	Total
Rutherford Clinical Category 2	34	15	49
Rutherford Clinical Category 3	183	55	238
Rutherford Clinical Category 4	4	1	5

Diabetes
Diabetes(Participants)	Paclitaxel-coated Balloon	Bare Balloon	Total
Count of participants	83	26	109

Hypertension
Hypertension(Participants)	Paclitaxel-coated Balloon	Bare Balloon	Total
Count of participants	173	60	233

Hyperlipidemia
Hyperlipidemia(Participants)	Paclitaxel-coated Balloon	Bare Balloon	Total
Count of participants	137	49	186

Smoking status
Smoking status(Participants)	Paclitaxel-coated Balloon	Bare Balloon	Total
Never Smoked	24	12	36
Previous or current	198	60	258

Baseline Ankle Brachial Index
Baseline Ankle Brachial Index(ratio)	Paclitaxel-coated Balloon	Bare Balloon	Total
Mean	0.72 ± 0.21	0.69 ± 0.26	0.71 ± 0.22

9 further baseline measures are reported on the registry.

Study locations

1 site

Center for Diagnostic Radiology and Minimally Invasive Therapy
Berlin, Germany

References and documents

Publications

Schroeder H, Werner M, Meyer DR, Reimer P, Kruger K, Jaff MR, Brodmann M; ILLUMENATE EU RCT Investigators. Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon). Circulation. 2017 Jun 6;135(23):2227-2236. doi: 10.1161/CIRCULATIONAHA.116.026493. Epub 2017 Apr 19. PubMed 28424223 ↗
Brodmann M, Werner M, Meyer DR, Reimer P, Kruger K, Granada JF, Jaff MR, Schroeder H; ILLUMENATE EU RCT Investigators. Sustainable Antirestenosis Effect With a Low-Dose Drug-Coated Balloon: The ILLUMENATE European Randomized Clinical Trial 2-Year Results. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2357-2364. doi: 10.1016/j.jcin.2018.08.034. PubMed 30522663 ↗
Lyden SP, Brodmann M, Parikh SA, Krishnan P, Schroeder H, Werner M, Holden A, Ouriel K, Tarra T, Gray WA. Four-year patient-level pooled mortality analysis of the ILLUMENATE US Pivotal and EU randomized controlled trials. J Vasc Surg. 2022 Feb;75(2):600-607. doi: 10.1016/j.jvs.2021.07.244. Epub 2021 Sep 8. PubMed 34506898 ↗
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 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Mar 2016 and a completion of Oct 2020. It does not say whether these dates are actual or estimated.

Results were first posted in Oct 2021, 5 years 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: May 8, 2013
First posted: May 21, 2013
Start: Nov 2012
Primary completionActual: Mar 2016
CompletionActual: Oct 2020
Results first posted: Oct 13, 2021
Last update: Oct 13, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01858363
Lead sponsor: Spectranetics Corporation
Responsible party: Sponsor
First posted: May 21, 2013
Start date: Nov 2012
Primary completion: Mar 2016
Completion: Oct 2020
Results posted: Oct 13, 2021
Last update: Oct 13, 2021

Study contacts

Henrik Schroeder, M.D.

principal investigator · Center for Diagnostic Radiology & Minimally Invasive Therapy, The Jewish Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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