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| Name | Class |
|---|---|
| B. Braun Melsungen AG | INDUSTRY |
| OrbusNeich | INDUSTRY |
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Percutaneous coronary intervention with stent implantation is limited on the one hand by restenosis due to smooth muscle cell proliferation and on the other hand by stent thrombosis due to incomplete or not sufficient enough endothelialization of stent struts. The Genous stent implantation allows a rapid layer over the stent struts with endothelial progenitor cells allowing a fast endothelialization and probably reducing the risk of stent thrombosis. Local therapy with drug-eluting balloons administering paclitaxel has been shown to reduce restenosis in in-stent restenosis and de-novo lesions in vessels with small reference diameter. The combination of a paclitaxel-eluting balloon and Genous stent implantation may summarized both advantages: a rapid endothelialization limiting the number of stent thrombosis and on the other hand a reduction of smooth muscle cell proliferation minimizing the risk of restenosis with the subsequent need for revascularization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Genous stent implantation with paclitaxel-eluting balloon therapy |
|
| 2 | Active Comparator | Genous stent implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genous stent implantation with paclitaxel-eluting balloon dilation | Device | Genous stent implantation with paclitaxel-eluting balloon therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late loss | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diameter stenosis | 6 months | |
| Binary restenosis rate | 6 month | |
| Late loss index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jochen Wöhrle, MD | University of Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Coburg | Coburg | 96450 | Germany | |||
| University of Ulm |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21617163 | Background | Wohrle J, Birkemeyer R, Markovic S, Nguyen TV, Sinha A, Miljak T, Spiess J, Rottbauer W, Rittger H. Prospective randomised trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery disease. Heart. 2011 Aug;97(16):1338-42. doi: 10.1136/hrt.2011.226563. Epub 2011 May 26. | |
| 26479969 |
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| Genous stent implantation | Device | Genous stent implantation |
|
| 6 months |
| Target lesion revascularization | 2, 6, 12, 24, 36, 48, 60 months |
| Target vessel revascularization | 2, 6, 12, 24, 36, 48, 60 months |
| Major adverse cardiac events | 2, 6, 12, 24, 36, 48, 60 months |
| Stent thrombosis | 2, 6, 12, 24, 36, 48, 60 months |
| Ulm |
| 89081 |
| Germany |
| Schwarzwald-Baar Klinikum | Villingen-Schwenningen | 78011 | Germany |
| Seeger J, Markovic S, Birkemeyer R, Rittger H, Jung W, Brachmann J, Rottbauer W, Wohrle J. Paclitaxel-coated balloon plus bare-metal stent for de-novo coronary artery disease: final 5-year results of a randomized prospective multicenter trial. Coron Artery Dis. 2016 Mar;27(2):84-8. doi: 10.1097/MCA.0000000000000314. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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