Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion

NCT ID: NCT02739685

Last Updated: 2019-09-26

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bioresorbable vascular scaffold

Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion

Group Type EXPERIMENTAL

Everolimus-eluting bioresorbable vascular scaffold

Intervention Type DEVICE

Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion

Stent

Implantation everolimus-eluting stent in chronic total occlusion

Group Type ACTIVE_COMPARATOR

Everolimus-eluting stent

Intervention Type DEVICE

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

Intervention Type DEVICE

Everolimus-eluting stent

Implantation of everolimus-eluting stent in chronic total occlusion

Intervention Type DEVICE

Eligibility Criteria

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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


* 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

* Limited long-term prognosis with a life-expectancy \<12 months
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Holger Thiele

Director, Department of Cardiology/Angiology/Intensive Care Medicine, University Heart Center Luebeck

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Luebeck

Lübeck, , Germany

Site Status

Countries

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Germany

Other Identifiers

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15-373

Identifier Type: -

Identifier Source: org_study_id

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