Advance® 18PTX® Balloon Catheter Study
Not Applicable
Completed
- Conditions
- Peripheral Arterial Disease
- Interventions
- Device: Advance® 18LP Balloon CatheterDevice: Advance® 18PTX® Balloon Catheter
- Registration Number
- NCT00776906
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
The Advance® 18 PTX® Balloon Catheter study is a clinical trial to study the safety and effectiveness of the Advance 18® PTX® Balloon Catheter in the treatment of lesions in the superficial femoral artery and popliteal artery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Age >18 years.
- Able to provide informed consent.
- Has at least one de novo or restenotic lesion(s) with > 70% stenosis documented angiographically of the SFA or popliteal artery. If more than one lesion requires intervention, only one should be treated as a study lesion.
Key
Exclusion Criteria
- Has significant stenosis (> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure.
- Lack of at least one patent runoff vessel with < 50% stenosis throughout its course.
- Lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Advance® 18LP Balloon Catheter Bare balloon 1 Advance® 18PTX® Balloon Catheter PTX-coated balloon
- Primary Outcome Measures
Name Time Method Evaluation of Late Lumen Loss 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Heart Center Leipzig/Park Hospital
🇩🇪Leipzig, Germany
Klinikum Rosenheim
🇩🇪Rosenheim, Germany
Endosurgery and Lithotripsy Center
🇷🇺Moscow, Russian Federation
Universitat Klinik Tubingen
🇩🇪Tubingen, Germany