Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion
NCT ID: NCT02739685
Last Updated: 2019-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
17 participants
INTERVENTIONAL
2016-09-30
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bioresorbable vascular scaffold
Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion
Everolimus-eluting bioresorbable vascular scaffold
Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion
Stent
Implantation everolimus-eluting stent in chronic total occlusion
Everolimus-eluting stent
Implantation of everolimus-eluting stent in chronic total occlusion
Interventions
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Everolimus-eluting bioresorbable vascular scaffold
Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion
Everolimus-eluting stent
Implantation of everolimus-eluting stent in chronic total occlusion
Eligibility Criteria
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Inclusion Criteria
* Angina pectoris, equivalent symptoms, and/or positive stress test
* Viable myocardium subtended by chronic total occlusion
* Negative pregnancy test in women with childbearing potential
* 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
* Contraindications to antiplatelet therapy
* Known allergy against cobalt chrome, everolimus, or polylactic acid
* 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
18 Years
ALL
No
Sponsors
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University of Luebeck
OTHER
Responsible Party
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Holger Thiele
Director, Department of Cardiology/Angiology/Intensive Care Medicine, University Heart Center Luebeck
Locations
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University of Luebeck
Lübeck, , Germany
Countries
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Other Identifiers
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15-373
Identifier Type: -
Identifier Source: org_study_id
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