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

Not Applicable

Terminated

• Conditions: Diabetes Mellitus; Coronary Artery Disease
• Interventions: Device: Absorb GT1; Device: Promus

• Registration Number: NCT02632292
• Lead Sponsor: University of Luebeck

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Study Start: 2016-01
• Primary Completion: 2017-01-03
• Study Completion: 2017-01-03
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absorb GT1	Absorb GT1	Bioresorbable everolimus-eluting scaffolds
Promus	Promus	Everolimus-eluting stents

Primary Outcome Measures

Name	Time	Method
In-stent late lumen loss	Angiography 8-10 months after the index procedure

Secondary Outcome Measures

Name	Time	Method
Device success	Baseline angiography	Attainment of \<30% final residual stenosis following the index procedure.
Cardiac death	12- and 24-months
In-segment late lumen loss	Angiography 8-10 months after the index procedure	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.
Myocardial infarction	12- and 24-months
Scaffold/stent thrombosis	12- and 24-months
Target lesion failure	12- and 24-months	Composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization
Procedure success	Baseline angiography	Device success and no periprocedural complications.
Vasomotion	Angiography 8-10 months after the index procedure	Change in minimal lumen diameter before and after nitrate administration assessed by angiography at 8-10 months.
Binary restenosis	Angiography 8-10 months after the index procedure	In-stent or in-segment restenosis ≥50% assessed by angiography at 8-10 months.
Conformability	Angiography 8-10 months after the index procedure	Change in curvature and angulation between preprocedure, postprocedure, and angiographic follow-up at 8-10 months.
Major adverse cardiac events	12- and 24-months	Composite of cardiac death, myocardial infarction, scaffold/stent thrombosis, and target vessel revascularization
Target vessel revascularization	12- and 24-months
Target vessel failure	12- and 24-months	Composite of cardiac death, target vessel related myocardial infarction, clinically driven target vessel revascularization, and scaffold/stent thrombosis
Clinical success	12- and 24-months	Procedure success and no major adverse cardiac events at 12- and 24-month clinical follow-up
Anginal status assessed by the Seattle Angina Questionnaire	12- and 24-months

Trial Locations

Locations (1)

University of Luebeck; 🇩🇪 Luebeck, Germany