Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries
NCT01594684 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 112
Last updated 2012-06-19
Summary
In stent restenosis in peripheral artery disease (superficial and popliteal artery) either treated with uncoated or paclitaxel coated balloons.
Conditions
- Catherization
Interventions
- DEVICE
-
balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.)
balloon inflation
- DEVICE
-
drug coated balloon inflation (Cotavance, Medrad Inc.)
Balloon inflation
- DEVICE
-
uncoated balloon (e.g. Admiral, Medtronic)
balloon inflation
- DEVICE
-
balloon inflation, drug coated balloon (Cotavance, Medrad Inc.)
ballon inflation
Sponsors & Collaborators
-
Zeller
collaborator UNKNOWN -
Duda
collaborator UNKNOWN -
Albrecht
collaborator UNKNOWN -
Reimer
collaborator UNKNOWN -
Brechtel
collaborator UNKNOWN -
Diehm
collaborator UNKNOWN -
Strausinsky
collaborator UNKNOWN -
Jahnke
collaborator UNKNOWN -
Huppert
collaborator UNKNOWN -
Amendt
collaborator UNKNOWN -
Prof. Dr. med. Gunnar Tepe
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2014-01-31
- Completion
- 2016-06-30
Countries
- Germany
Study Locations
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