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Clinical Trials/NCT02739685
NCT02739685
Terminated
Not Applicable

Everolimus-eluting Bioresorbable Vascular Scaffolds Versus Everolimus-eluting Stents in Patients With Chronic Total Occlusion

University of Luebeck1 site in 1 country17 target enrollmentSeptember 2016
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ConditionsCoronary Artery Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University of Luebeck
Enrollment
17
Locations
1
Primary Endpoint
In-stent late lumen loss assessed by angiography
Status
Terminated
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
January 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Luebeck
Responsible Party
Principal Investigator
Principal Investigator

Holger Thiele

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

University of Luebeck

Eligibility Criteria

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

Outcomes

Primary Outcomes

In-stent late lumen loss assessed by angiography

Time Frame: 8-10 months after the index procedure

Study Sites (1)

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