ILLUMENATE EU Randomized Clinical Trial (EU RCT)

Spectranetics

Status: Completed

Conditions: Claudication; Peripheral Arterial Disease

Treatments: Device: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter; Device: Bare Percutaneous Transluminal Angioplasty Balloon Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01858363

TP 1360

Details and patient eligibility

About

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.

Enrollment: 294 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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294 participants in 2 patient groups, including a placebo group

Paclitaxel-coated balloon

Experimental group

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.

Treatment:

Device: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

Bare balloon

Placebo Comparator group

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.

Treatment:

Device: Bare Percutaneous Transluminal Angioplasty Balloon Catheter