Peripheral Arterial DiseaseEU RCTNCT01858363

ILLUMENATE EU Randomized Clinical Trial

A study testing CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter and Bare Percutaneous Transluminal Angioplasty Balloon Catheter in people with Peripheral Arterial Disease and Claudication, run by Spectranetics Corporation at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Arterial Disease, Claudication
What is being tested?: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter and Bare Percutaneous Transluminal Angioplasty Balloon Catheter
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 294 participants
Where: 1 siteGermany
Study dates: Nov 2012to Oct 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Center for Diagnostic Radiology and Minimally Invasive Therapy
Berlin

Other trials in Germany

About this study

Official title: Prospective, Randomized, Multi-center, Single-blinded Study for the Treatment of Subjects Presenting With De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using Paclitaxel or Bare Percutaneous Transluminal Angioplasty Balloon Catheter

Conditions: Peripheral Arterial Disease, Claudication
Being tested: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter, Bare Percutaneous Transluminal Angioplasty Balloon Catheter
Keywords: Peripheral arterial disease, claudication, drug-coated balloon, drug-eluting balloon
Medical subject headings: Peripheral Arterial Disease, Intermittent Claudication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterDevice
Bare Percutaneous Transluminal Angioplasty Balloon CatheterDevice

Study groups in NCT01858363
Study group	Role	What they receive
Paclitaxel-coated balloon	Experimental	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. Receives: Device: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Bare balloon	Placebo comparator	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. Receives: Device: Bare Percutaneous Transluminal Angioplasty Balloon Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 30-Days and 12-Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Oct 2020

First posted21 May 2013 (estimated)
Study startNov 2012
Primary completionMar 2016
Study completionOct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 294 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01858363
Sponsor's protocol ID: TP 1360
Acronym: EU RCT
Status last verified: Oct 2021
First submitted: 8 May 2013
Last updated: 13 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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
Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
PubMed 42573020
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
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Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
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All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Randomized, Multi-center, Single-blinded Study for the Treatment of Subjects Presenting With De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using Paclitaxel or Bare Percutaneous Transluminal Angioplasty Balloon Catheter
ClinicalTrials.gov ID: NCT01858363
Acronym / sponsor ID: EU RCT / TP 1360
Conditions: Peripheral Arterial Disease, Claudication
Keywords: Peripheral arterial disease, claudication, drug-coated balloon, drug-eluting balloon
Study type: Interventional
Recruitment status: Completed
Enrolment: 294 participants (actual)
Lead sponsor: Spectranetics CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Mar 2016 (actual)
Study completion: Oct 2020 (actual)
First posted: 21 May 2013 (estimated)
Results: Posted 13 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	Device	Paclitaxel-coated balloon
Bare Percutaneous Transluminal Angioplasty Balloon Catheter	Device	Bare balloon

Primary outcome

Patency at 12-months
Time frame: 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).
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
Time frame: 30-Days and 12-Months
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.

Results and safety

Results posted to the registry on 13 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paclitaxel-coated Balloon	222	146
Bare Balloon	72	46

Primary outcome: Patency at 12-months

Time frame: 12 months. Number (95% Confidence Interval). Unit: percentage of lesions

Measure	Paclitaxel-coated Balloon n = 222	Bare Balloon n = 72
Value	83.9 (78.5 to 88.5)	60.6 (47.8 to 72.4)

Population analysed: The analysis for the primary patency was based on the lesion success and not participant success. In the Paclitaxel-coated balloon arm, 222 subjects represents 254 lesions. Of those 254 lesions, only 224 lesions were evaluable. In the Bare balloon arm, 72 subjects represents 79 lesions. Of those 79 lesions, only 66 lesions were evaluable.

Primary outcome: 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

Time frame: 30-Days and 12-Months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Paclitaxel-coated Balloon n = 222	Bare Balloon n = 72
Value	94.1 (90.0 to 96.9)	83.3 (71.5 to 91.7)

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paclitaxel-coated Balloon	118 of 219 (53.9%)	180 of 219 (82.2%)	35 of 219
Bare Balloon	38 of 68 (55.9%)	51 of 68 (75%)	9 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28424223Schroeder 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.
Results publication: PubMed 30522663Brodmann 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.
Derived from this study: PubMed 42573020Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
Derived from this study: PubMed 34506898Lyden 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.
Derived from this study: PubMed 31567024Gray 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.
Individual participant dataSharing planned: No

Related trials for Peripheral Arterial Disease

Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
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Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
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RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Henrik Schroeder, M.D. principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patency at 12-months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01858363, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.