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ILLUMENATE EU Randomized Clinical Trial

NCT ID: NCT01858363

Last Updated: 2021-10-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2020-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Arterial Disease Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

Intervention Type DEVICE

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.

Group Type PLACEBO_COMPARATOR

Bare Percutaneous Transluminal Angioplasty Balloon Catheter

Intervention Type DEVICE

Interventions

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CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

Intervention Type DEVICE

Bare Percutaneous Transluminal Angioplasty Balloon Catheter

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spectranetics Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henrik Schroeder, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Center for Diagnostic Radiology and Minimally Invasive Therapy

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 28424223 (View on PubMed)

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.

Reference Type RESULT
PMID: 30522663 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34506898 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31567024 (View on PubMed)

Other Identifiers

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TP 1360

Identifier Type: -

Identifier Source: org_study_id