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| Name | Class |
|---|---|
| Translumina GmbH | INDUSTRY |
Revascularisation procedures such as percutaneous coronary intervention are associated with overall worse outcomes in patients with diabetes mellitus. Implantation of coronary stents is associated with higher restenosis rates compared to non-diabetic individuals.
There is only limited data available on the efficacy and safety of the novel Yukon Choice drug-eluting stent system specifically in patients with diabetes mellitus. The trial will determine the efficacy and safety of the novel Yukon Choice stent system compared to the well established Taxus Liberté stent system. The primary endpoint will be "in-stent late lumen loss" at 9 months as determined by invasive angiography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yukon Choice stent system | Device | coronary stent implantation |
| |
| Taxus Liberté stent system |
| Measure | Description | Time Frame |
|---|---|---|
| "In-stent late lumen loss" at follow-up-angiography (9 months) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Binary restenosis | 9 months | |
| Target vessel revascularisation rate | 9 months | |
| Target lesion revascularisation rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holger Thiele, MD | Heart Center Leipzig - University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leipzig Heart Center | Leipzig | 04289 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23873579 | Derived | Stiermaier T, Heinz A, Schloma D, Kleinertz K, Danschel W, Erbs S, Linke A, Boudriot E, Lauer B, Schuler G, Thiele H, Desch S. Five-year clinical follow-up of a randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus (LIPSIA Yukon trial). Catheter Cardiovasc Interv. 2014 Feb 15;83(3):418-24. doi: 10.1002/ccd.25131. Epub 2013 Aug 9. | |
| 21511226 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Device |
coronary stent implantation |
|
| 9 months |
| Late loss (in-segment) | 9 months |
| MLD und diameter of stenosis (%) | 9 months |
| Death | 9 months |
| Success rate index procedure (residual diameter stenosis < 30%) | 0 months |
| Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization) | 9 months |
| Derived |
| Desch S, Schloma D, Mobius-Winkler S, Erbs S, Gielen S, Linke A, Yu J, Lauer B, Kleinertz K, Danschel W, Schuler G, Thiele H. Randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus: the LIPSIA Yukon trial. JACC Cardiovasc Interv. 2011 Apr;4(4):452-9. doi: 10.1016/j.jcin.2010.11.016. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |