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| Name | Class |
|---|---|
| B. Braun Melsungen AG | INDUSTRY |
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The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A 1 | Active Comparator | paclitaxel eluting PTCA balloon (SeQuent please) after bare-metal stenting of a chronic total occlusion in a native coronary artery |
|
| A2 | Active Comparator | historical population of patients with a chronic total occlusion in a native coronary artery treated with the paclitaxel eluting Taxus stent (Boston Scientific) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel eluting PTCA balloon catheter (SeQuent Please) | Device | paclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery |
| Measure | Description | Time Frame |
|---|---|---|
| Late loss | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| percent diameter stenosis | 6 months | |
| binary angiographic restenosis rate | 6 months | |
| late loss index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jochen Wöhrle, MD; FESC | University of Ulm, Ulm, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Darmstadt | Darmstadt | 64283 | Germany | |||
| University of Ulm |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22511572 | Background | Wohrle J, Werner GS. Paclitaxel-coated balloon with bare-metal stenting in patients with chronic total occlusions in native coronary arteries. Catheter Cardiovasc Interv. 2013 Apr;81(5):793-9. doi: 10.1002/ccd.24409. Epub 2012 Nov 8. |
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|
| paclitaxel eluting Taxus stent (Boston Scientific) | Device | paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries |
|
| 6 months |
| Target lumen revascularization | 30 days, 6, 12, 24 months |
| target vessel revascularization | 30 days, 6, 12, 24 months |
| major adverse cardiac events | 30 days, 6, 12, 24 months |
| Ulm |
| 89081 |
| Germany |
| 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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