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Slow enrollment, access to devices
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The purpose of the current study is to demonstrate non-inferiority of everolimus-eluting bioresorbable vascular scaffold to everolimus-eluting stents in patients with chronic total occlusion regarding the antirestenotic efficacy at 8 to 10-month angiographic follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioresorbable vascular scaffold | Experimental | Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion |
|
| Stent | Active Comparator | Implantation everolimus-eluting stent in chronic total occlusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus-eluting bioresorbable vascular scaffold | Device | Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-stent late lumen loss assessed by angiography | 8-10 months after the index procedure |
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Inclusion Criteria:
Clinical inclusion criteria:
Angiographic inclusion criteria:
Exclusion Criteria:
Clinical exclusion criteria:
Angiographic exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Luebeck | Lübeck | 23538 | Germany |
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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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| Everolimus-eluting stent | Device | Implantation of everolimus-eluting stent in chronic total occlusion |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |