ABILITY Diabetes Global
ABILITY Diabetes Global is a prospective, multi-center, multinational, randomized, open label (follow-ups blinded), 2-arm parallel groups study. The objective is to compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus-eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). The objective is to enroll 3000 diabetic patients eligible for PCI at 100 investigational sites and patients will be followed up to two years after procedure.
- Ischemia-driven Target Lesion Revascularization (idTLR) at 1-year follow-up (powered for non-inferiority and sequentially superiority).
- Target lesion failure (TLF – composite of cardiovascular death, target vessel myocardial infarction [MI], or ischemia driven target lesion revascularization) at 1-year follow-up, powered for non-inferiority
Clinical trial documentation,
Set-up activities (sites selection, insurance management, contract management),
Around 20 countries across Europe, Asia, Australia, Latin America and Japan.
Europe: Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Poland, Sweden, Switzerland, The Netherlands and United Kingdom.
Asia: Bangladesh, India, Malaysia, Singapore, South Korea, Taiwan.
Latin America: Brazil and Mexico
100 investigational centers