Coronary Artery Disease
Conditions
Brief summary
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.
Interventions
Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion
Implantation of everolimus-eluting stent in chronic total occlusion
Sponsors
Study design
Eligibility
Inclusion criteria
Clinical inclusion criteria: * Age ≥18 years * Angina pectoris, equivalent symptoms, and/or positive stress test * Viable myocardium subtended by chronic total occlusion * Negative pregnancy test in women with childbearing potential Angiographic inclusion criteria: * Chronic total occlusion defined as Thrombolysis in Myocardial Infarction flow 0 with an estimated duration ≥3 months * Successful wire passage and assumption of successful stent/scaffold deployment * Target reference vessel diameter 2.5 - 4.0 mm
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent late lumen loss assessed by angiography | 8-10 months after the index procedure |
Countries
Germany