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

University of Luebeck33 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Coronary Artery Disease Diabetes Mellitus

Interventions

Absorb GT1DEVICE

Bioresorbable vascular scaffold

PromusDEVICE

Everolimus-eluting stent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Clinical inclusion criteria: * 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 Angiographic inclusion criteria: * 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 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 * 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

Locations (1)

University of Luebeck

Lübeck, Germany

Outcomes

Primary Outcomes

In-stent late lumen loss

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

Secondary Outcomes

Device success

Attainment of \<30% final residual stenosis following the index procedure.

Time frame: Baseline angiography

Procedure success

Device success and no periprocedural complications.

Time frame: Baseline angiography

Vasomotion

Change in minimal lumen diameter before and after nitrate administration assessed by angiography at 8-10 months.

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

In-segment late lumen loss

Difference between the immediate post-procedure in-stent minimal lumen diameter and the in-stent minimal lumen diameter assessed by angiography at 8-10 months inside the stent or within 5 mm proximal or distal to the stent.

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

Binary restenosis

In-stent or in-segment restenosis ≥50% assessed by angiography at 8-10 months.

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

Conformability

Change in curvature and angulation between preprocedure, postprocedure, and angiographic follow-up at 8-10 months.

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

Major adverse cardiac events

Data from ClinicalTrials.gov

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