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

NCT02632292 | Terminated

• 1 other identifier: 15-260
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• In-stent late lumen loss

  Angiography 8-10 months after the index procedure

Secondary Outcomes (15)

• Device success

  Baseline angiography

• Procedure success

  Baseline angiography

• Vasomotion

  Angiography 8-10 months after the index procedure

• In-segment late lumen loss

  Angiography 8-10 months after the index procedure

• Binary restenosis

  Angiography 8-10 months after the index procedure

Study Arms (2)

Absorb GT1

EXPERIMENTAL

Bioresorbable everolimus-eluting scaffolds

Device: Absorb GT1

Promus

ACTIVE COMPARATOR

Everolimus-eluting stents

Device: Promus

Interventions

Absorb GT1 DEVICE

Bioresorbable vascular scaffold

Absorb GT1

Promus DEVICE

Everolimus-eluting stent

Promus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Luebeck: lead
• University Hospital Schleswig-Holstein: collaborator
• Kerckhoff Klinik: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

University of Luebeck

Lübeck, 23538, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 16, 2015
• Study Start: January 1, 2016
• Primary Completion: January 3, 2017
• Study Completion: January 3, 2017
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

DE (1)