Back to resultsILLUMENATE EU Randomized Clinical Trial (EU RCT)
Primary Purpose
Peripheral Arterial Disease, Claudication
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Bare Percutaneous Transluminal Angioplasty Balloon Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral arterial disease, claudication, drug-coated balloon, drug-eluting balloon
Eligibility Criteria
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
Sites / Locations
- Center for Diagnostic Radiology and Minimally Invasive Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Paclitaxel-coated balloon
Bare balloon
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01858363
First Posted
May 8, 2013
Last Updated
October 11, 2021
Sponsor
Spectranetics Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01858363
Brief Title
ILLUMENATE EU Randomized Clinical Trial
Acronym
EU RCT
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
October 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectranetics Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Claudication
Keywords
Peripheral arterial disease, claudication, drug-coated balloon, drug-eluting balloon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
294 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel-coated balloon
Arm Type
Experimental
Arm Description
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.
Arm Title
Bare balloon
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Intervention Type
Device
Intervention Name(s)
Bare Percutaneous Transluminal Angioplasty Balloon Catheter
Primary Outcome Measure Information:
Title
Patency at 12-months
Description
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
Title
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
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Schroeder, M.D.
Organizational Affiliation
Center for Diagnostic Radiology & Minimally Invasive Therapy, The Jewish Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Diagnostic Radiology and Minimally Invasive Therapy
City
Berlin
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28424223
Citation
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.
Results Reference
result
PubMed Identifier
30522663
Citation
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.
Results Reference
result
PubMed Identifier
34506898
Citation
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.
Results Reference
derived
PubMed Identifier
31567024
Citation
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.
Results Reference
derived
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ILLUMENATE EU Randomized Clinical Trial
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