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Clinical Trials/NCT02632292
NCT02632292
Terminated
Not Applicable

EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus

University of Luebeck1 site in 1 country33 target enrollmentJanuary 2016
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ConditionsCoronary Artery DiseaseDiabetes Mellitus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University of Luebeck
Enrollment
33
Locations
1
Primary Endpoint
In-stent late lumen loss
Status
Terminated
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Prospective, randomized, controlled, multicenter, open-label study to compare everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients with diabetes mellitus.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
January 3, 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

Principal Investigator

University of Luebeck

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

In-stent late lumen loss

Time Frame: Angiography 8-10 months after the index procedure

Secondary Outcomes

  • Device success(Baseline angiography)
  • Cardiac death(12- and 24-months)
  • In-segment late lumen loss(Angiography 8-10 months after the index procedure)
  • Myocardial infarction(12- and 24-months)
  • Scaffold/stent thrombosis(12- and 24-months)
  • Target lesion failure(12- and 24-months)
  • Procedure success(Baseline angiography)
  • Vasomotion(Angiography 8-10 months after the index procedure)
  • Binary restenosis(Angiography 8-10 months after the index procedure)
  • Conformability(Angiography 8-10 months after the index procedure)
  • Major adverse cardiac events(12- and 24-months)
  • Target vessel revascularization(12- and 24-months)
  • Target vessel failure(12- and 24-months)
  • Clinical success(12- and 24-months)
  • Anginal status assessed by the Seattle Angina Questionnaire(12- and 24-months)

Study Sites (1)

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