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

University of Luebeck

Status: Terminated

Conditions: Coronary Artery Disease; Diabetes Mellitus

Treatments: Device: Absorb GT1; Device: Promus

Study type: Interventional

Funder types: Other

Identifiers

NCT02632292

15-260

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

Absorb GT1

Experimental group

Description:

Bioresorbable everolimus-eluting scaffolds

Treatment:

Device: Absorb GT1

Promus

Active Comparator group

Description:

Everolimus-eluting stents

Treatment:

Device: Promus