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

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

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease; Diabetes Mellitus
• Intervention / Treatment: Device: Absorb GT1; Device: Promus

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Luebeck, Germany, 23538
    • University of Luebeck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Absorb GT1; Bioresorbable everolimus-eluting scaffolds	Device: Absorb GT1; Bioresorbable vascular scaffold
Active Comparator: Promus; Everolimus-eluting stents	Device: Promus; Everolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-stent late lumen loss	Angiography 8-10 months after the index procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Luebeck
• Collaborators: Charite University, Berlin, Germany; Kerckhoff Klinik; University of Schleswig-Holstein, Campus Kiel, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 3, 2017
• Study Completion (Actual): January 3, 2017

Study Registration Dates

• First Submitted: December 3, 2015
• First Submitted That Met QC Criteria: December 11, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Coronary Disease; Coronary Artery Disease; Diabetes Mellitus
• Other Study ID Numbers: 15-260