Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries
NCT00472472 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 87
Last updated 2010-06-30
Summary
The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty.
Conditions
- Peripheral Arterial Disease
Interventions
- DEVICE
-
paclitaxel coated balloon catheter (device with drug)
PTA vs Paccocath
Sponsors & Collaborators
-
University Hospital, Saarland
lead OTHER
Principal Investigators
-
Jens Ricke, MD · Klinik für Strahlenheilkunde, Charité Campus Virchow, Augustenburger Platz 1, 13353 Berlin, Germany
-
Ulrich Speck, PhD · Radiologie, Campus Mitte, Charite, 10117 Berlin, Germany
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 95 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-04-30
- Primary Completion
- 2007-07-31
- Completion
- 2007-07-31
Countries
- Germany
Study Locations
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