Trials / Completed
CompletedNCT00664963
YUKON-drug-eluting Stent Below The Knee - Randomised Double-blind Study
YUKON-drug-eluting Stent Below The Knee - Prospective Randomized Double-blind Multicenter Study
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 130 (actual)
- Sponsor
- Herz-Zentrums Bad Krozingen · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the effectiveness of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease.
Detailed description
Based on the fact that drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries, we assume that YUKON-BTX-Sirolimus-eluting stent has a superior restenosis rate compared to treatment with uncoated stent in the below-the-knee arteries consecutively. The purpose of this study is to compare the restenosis rate of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease. Randomisation will be performed by extremity, that may lead to varying treatments within one patient during the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implantation of YUKON Sirolimus-eluting Stent | Implantation of YUKON Sirolimus-eluting Stent |
| DEVICE | Implantation of YUKON Stent (uncoated) | Implantation of YUKON Stent (uncoated) |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2010-03-01
- Completion
- 2010-04-01
- First posted
- 2008-04-23
- Last updated
- 2014-12-17
Locations
3 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00664963. Inclusion in this directory is not an endorsement.