Trials / Unknown
UnknownNCT01594684
Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries
Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries COPA CABANA Study
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- Sponsor
- Prof. Dr. med. Gunnar Tepe · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In stent restenosis in peripheral artery disease (superficial and popliteal artery) either treated with uncoated or paclitaxel coated balloons.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2014-01-01
- Completion
- 2016-06-01
- First posted
- 2012-05-09
- Last updated
- 2012-06-19
Locations
6 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01594684. Inclusion in this directory is not an endorsement.