ILLUMENATE EU Randomized Clinical Trial

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

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.

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