ABILITY Diabetes Global

Brief summary:

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.

Primary endpoints:

  • 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

CERC Services:

Clinical trial documentation,

Submission,

Set-up activities (sites selection, insurance management, contract management),

Project Management,

Monitoring,

CoreLab activities,

Safety reporting,

Clinical report

 

Countries:

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

 

Center number :

100 investigational centers