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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | YUKON Sirolimus-eluting Stent |
|
| 2 | Active Comparator | YUKON Stent (uncoated) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of YUKON Sirolimus-eluting Stent | Device | Implantation of YUKON Sirolimus-eluting Stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of reinterventions of target vessel | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Zeller, MD | Herz-Zentrum Bad Krozingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz-Zentrums Bad Krozingen | Bad Krozingen | 79189 | Germany | |||
| Universitäres Herzzentrum Hamburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22878166 | Derived | Rastan A, Brechtel K, Krankenberg H, Zahorsky R, Tepe G, Noory E, Schwarzwalder U, Macharzina R, Schwarz T, Burgelin K, Sixt S, Tubler T, Neumann FJ, Zeller T. Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial. J Am Coll Cardiol. 2012 Aug 14;60(7):587-91. doi: 10.1016/j.jacc.2012.04.035. | |
| 21622669 |
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| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Implantation of YUKON Stent (uncoated) |
| Device |
Implantation of YUKON Stent (uncoated) |
|
| Hamburg |
| 22527 |
| Germany |
| University Hospital of Tübingen | Tübingen | 72076 | Germany |
| Derived |
| Rastan A, Tepe G, Krankenberg H, Zahorsky R, Beschorner U, Noory E, Sixt S, Schwarz T, Brechtel K, Bohme C, Neumann FJ, Zeller T. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J. 2011 Sep;32(18):2274-81. doi: 10.1093/eurheartj/ehr144. Epub 2011 May 26. |