EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus (SUGAR-EVE)

This study has been terminated.

(Slow enrollment)

Sponsor:

Collaborators:

University of Schleswig-Holstein, Campus Kiel, Germany

Kerckhoff Klinik

Charite University, Berlin, Germany

Information provided by (Responsible Party):

Holger Thiele, University of Luebeck

ClinicalTrials.gov Identifier:

NCT02632292

First received: December 3, 2015

Last updated: April 12, 2017

Last verified: April 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

December 3, 2015

Last Updated Date

April 12, 2017

Start Date ^ICMJE

January 2016

Estimated Primary Completion Date

April 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

In-stent late lumen loss [ Time Frame: Angiography 8-10 months after the index procedure ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT02632292 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Device success [ Time Frame: Baseline angiography ]
Attainment of <30% final residual stenosis following the index procedure.
Procedure success [ Time Frame: Baseline angiography ]
Device success and no periprocedural complications.
Vasomotion [ Time Frame: 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.
In-segment late lumen loss [ Time Frame: 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.
Binary restenosis [ Time Frame: Angiography 8-10 months after the index procedure ]
In-stent or in-segment restenosis ≥50% assessed by angiography at 8-10 months.
Conformability [ Time Frame: 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 [ Time Frame: 12- and 24-months ]
Composite of cardiac death, myocardial infarction, scaffold/stent thrombosis, and target vessel revascularization
Cardiac death [ Time Frame: 12- and 24-months ]
Myocardial infarction [ Time Frame: 12- and 24-months ]
Scaffold/stent thrombosis [ Time Frame: 12- and 24-months ]
Target vessel revascularization [ Time Frame: 12- and 24-months ]
Target lesion failure [ Time Frame: 12- and 24-months ]
Composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization
Target vessel failure [ Time Frame: 12- and 24-months ]
Composite of cardiac death, target vessel related myocardial infarction, clinically driven target vessel revascularization, and scaffold/stent thrombosis
Clinical success [ Time Frame: 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 [ Time Frame: 12- and 24-months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease
Diabetes Mellitus

Intervention ^ICMJE

Device: Absorb GT1
Bioresorbable vascular scaffold
Device: Promus
Everolimus-eluting stent

Study Arms

Experimental: Absorb GT1
Bioresorbable everolimus-eluting scaffolds

Intervention: Device: Absorb GT1
Active Comparator: Promus
Everolimus-eluting stents

Intervention: Device: Promus

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

January 2019

Estimated Primary Completion Date

April 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02632292

Other Study ID Numbers ^ICMJE

15-260

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Holger Thiele, University of Luebeck

Study Sponsor ^ICMJE

University of Luebeck

Collaborators ^ICMJE

University of Schleswig-Holstein, Campus Kiel, Germany
Kerckhoff Klinik
Charite University, Berlin, Germany

Investigators ^ICMJE

Not Provided

PRS Account

University of Luebeck

Verification Date

April 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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