Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion
Not Applicable
Terminated
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT02739685
- Lead Sponsor
- University of Luebeck
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
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 exclusion criteria:
- Limited long-term prognosis with a life-expectancy <12 months
- Contraindications to antiplatelet therapy
- Known allergy against cobalt chrome, everolimus, or polylactic acid
Angiographic exclusion criteria:
- Target lesion located in the left main trunk
- Target lesion located in a coronary bypass graft
- Bifurcation lesion with planned two-stent strategy
- Indication for coronary artery bypass grafting
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method In-stent late lumen loss assessed by angiography 8-10 months after the index procedure
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of everolimus-eluting bioresorbable vascular scaffolds in coronary artery disease?
How does the efficacy of bioresorbable vascular scaffolds compare to metallic stents in chronic total occlusion patients?
Which biomarkers are associated with restenosis risk in patients treated with bioresorbable vascular scaffolds?
What are the long-term adverse event profiles of everolimus-eluting stents versus bioresorbable vascular scaffolds in CTO treatment?
Are there combination therapies or competitor devices that improve outcomes for chronic total occlusion compared to NCT02739685 interventions?
Trial Locations
- Locations (1)
University of Luebeck
🇩🇪Luebeck, Germany
University of Luebeck🇩🇪Luebeck, Germany