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

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

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

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