ILLUMENATE EU Randomized Clinical Trial

Study Overview
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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.

Official Title
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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
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Peripheral Arterial Disease, Claudication

Intervention / Treatment
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* Device: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
* Device: Bare Percutaneous Transluminal Angioplasty Balloon Catheter


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel-coated balloon<br>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<br> <br> |
| Placebo Comparator: Bare balloon<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 30-Days and 12-Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral arterial disease, claudication, drug-coated balloon, drug-eluting balloon