CVI Drug Coated Balloon European Randomized Clinical Trial
This trial is active, not recruiting.
|Conditions||peripheral arterial disease, claudication|
|Treatments||cvi paclitaxel-coated percutaneous transluminal angioplasty balloon catheter, bare percutaneous transluminal angioplasty balloon catheter|
|Start date||November 2012|
|End date||March 2016|
|Trial size||360 participants|
|Trial identifier||NCT01858363, TP 1360|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Primary Efficacy Endpoint
time frame: 12 months
Primary Safety Endpoint
time frame: 30-Days and 12-Months
Male or female participants at least 18 years old.
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
|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|
|Principal investigator||Henrik Schroeder, M.D.|
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