Ability- DM Global - Concept Medical Inc.
Concept Medical Inc. - Best Heart Care Institute in Surat

ABILITY DM GLOBAL

Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents versus
Everolimus-Eluting Stents in Coronary Artery Disease Patients with Diabetes Mellitus


Design:

Prospective, multicentre, multinational, randomized, open-label, 2-arm parallel groups

Objective:

To compare diabetic patients eligible for PCI with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ Sirolimus-Eluting Stents (SES) versus Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with the acute coronary syndrome.

Efficacy Endpoint:

  • Primary Endpoint:
  • Target lesion failure (composite of cardiac death, target vessel myocardial infarction [MI], or ischemia-driven target lesion revascularization [TLR] ), powered for non-inferiority;
  • Ischemia-driven TLR at 1-year FU (powered for non-inferiority and sequentially superiority).
  • Secondary Endpoint:
  • Safety composite endpoint of the occurrence of cardiac death and target-vessel myocardial infarction (MI) at 1 year (non-inferiority);
  • In case the co-primary TLR endpoint (TLR for non-inferiority) will be demonstrated at 1 year, then the occurrence of ischemia-driven TLR at 2 years FU will be evaluated (efficacy endpoint – superiority);
  • Composite of cardiac death, target vessel MI and ischemia-driven TLR (TLF) at 1 year.
  • Others:
  • Composite of cardiac death, target vessel MI and ischemia-driven TLR (TLF) at 2 years;
  • Occurrence of cardiac death and target-vessel myocardial infarction (MI) at 2 years;
  • All-cause mortality up to 2 years from procedure;
  • Stroke up to 2 years from procedure;
  • Stent thrombosis (defined for grade and timing according to the Academic Research Consortium);
  • Technical success;
  • Clinical procedural success;
  • Occurrence of ischemia-driven TLR at 2 year FU;
  • Target vessel revascularization (TVR) up to 2 years.
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