At a glance
ClinicalIndex Comparison RecordN/ACompleted· 294 enrolled
Drug / intervention
CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter and Bare Percutaneous Transluminal Angioplasty Balloon Catheter for Peripheral Arterial Disease and Claudication. Completed, enrolled 294 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease, Claudication
CountriesGermany
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedMay 2013
Primary CompletionMar 2016
Study CompletionOct 2020
TodayJul 2026
First PostedMay 21, 2013
Enrollment StartNov 1, 2012
Primary CompletionMar 1, 2016
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.1 years ago
Interventions
CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheterdevice
Bare Percutaneous Transluminal Angioplasty Balloon Catheterdevice