Ability Diabetes Global Clinical Trial - Sirolimus Drug Eluting Stent
ABILITY DIABETES GLOBAL

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

  • More than 3000
    Diabetic Patients
  • More than 100 centers across 25 countries
  • RCT of Abluminus vs EES
STUDY DESIGN

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). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome Study

Prospective, multicenter, multinational, randomized, 2-arm parallel groups

 PRIMARY END PONT

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 FU, powered for non-inferiority

 SECONDARY END PONT

Safety composite endpoint of the occurrence of cardiovascular 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 idTLR at 2-year FU will be evaluated (efficacy endpoint – superiority)

Composite of cardiovascular death, target vessel MI and idTLR (TLF) at 1 year

Bleeding BARC 2 or greater

OTHERS

Composite of cardiovascular death, target vessel MI and idTLR (TLF) at 2 years

The occurrence of cardiovascular death and target-vessel myocardial infarction (MI) at 2 years

All-cause mortality up to 2 years from the procedure

Stroke up to 2 years from the procedure

Stent thrombosis (defined for grade and timing according to the Academic Research Consortium2)

Technical success

Clinical procedural success

The occurrence of idTLR at 2-year FU

Target vessel revascularization (TVR) up to 2 years

SCHEDULE OF CLINICAL AND LABORATORY EVALUATIONS

Follow-up visits are planned at 30 days (± 7 days), 6 months (± 30 days), 12 months (± 30 days), and 24 months (± 30 days) after enrollment. The follow-up schedule and assessments performed are designed to fall within routine follow-up for the patient population

PRINCIPAL INVESTIGATOR

Prof. Antonio Colombo
Director EMO GVM – Centro Cuore Columbus,
Via Michelangelo Buonarroti, 48, 20145 Milano MI, Italy
Maria Cecila Hospital, GVM, Cotignola, RA, Italy

Prof. Alexandre Abizaid
Instituto Dante Pazzanese de Cardiologia
Av. Dr Dante Pazzanese, 500 – Vila Mariana,
São Paulo – SP, 04012-909, Brazil

Prof. Shigeru Saito
Shonan Kamakura General Hospital
1370-1 Okamoto, Kamakura
Kanagawa 247-8533, Japan