EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus
NCT ID: NCT02632292
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
33 participants
INTERVENTIONAL
2016-01-31
2017-01-03
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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Absorb GT1
Bioresorbable everolimus-eluting scaffolds
Absorb GT1
Bioresorbable vascular scaffold
Promus
Everolimus-eluting stents
Promus
Everolimus-eluting stent
Interventions
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Absorb GT1
Bioresorbable vascular scaffold
Promus
Everolimus-eluting stent
Eligibility Criteria
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Inclusion Criteria
* DM type I or II based on the definitions of the American Diabetes Association
* Angiographically proven CAD
* Angina pectoris, equivalent symptoms, and/or positive stress test, and/or instantaneous flow reserve ≤0.86, and/or fractional flow reserve ≤0.80
* Negative pregnancy test in women with childbearing potential
* De-novo lesion in at least one native coronary artery
* Luminal diameter reduction 50-99% assessed by visual estimation
* 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
* Severe calcification of the target lesion as determined by angiography
* In-stent restenosis
* Bifurcation lesion with planned two-stent strategy
* Chronic total occlusion
* Indication for CABG
18 Years
ALL
No
Sponsors
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University Hospital Schleswig-Holstein
OTHER
Kerckhoff Klinik
OTHER
Charite University, Berlin, Germany
OTHER
University of Luebeck
OTHER
Responsible Party
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Holger Thiele
Principal Investigator
Locations
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University of Luebeck
Lübeck, , Germany
Countries
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Other Identifiers
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15-260
Identifier Type: -
Identifier Source: org_study_id
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