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
This study aims to determine which DES will best treat the diabetic population. Specifically, the research question of this trial is to evaluate the use of a novel sirolimus-eluting stent coated with drug-eluting polymer after crimping on the balloon as compared to the standard-of-care EES in the treatment of de novo coronary artery disease in patients with diabetes mellitus. ABILITY is a prospective, multi-center, multinational, randomized, open label, 2-arm parallel group, post-approval study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
3,050
The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA
The Prince Charles Hospital
Chermside, Australia
St Vincent Hospital
Melbourne, Australia
The Wollongong Hospital
Wollongong, Australia
University Heart Center Graz
Graz, Austria
Kardinal Schwarzenberg Klinikum
Schwarzach im Pongau, Austria
National Heart Foundation Hospital & Research Institute
Rate of Ischemia-driven TLR
powered for non-inferiority and sequentially superiority
Time frame: 1 year FU
Rate of Target lesion failure TLF
composite of cardiovascular death, target vessel myocardial infarction \[MI\], or ischemia driven target lesion revascularization \[idTLR\])
Time frame: 1 year FU, powered for non-inferiority
Safety composite endpoint
Safety composite endpoint of the occurrence of cardiovascular death and target-vessel myocardial infarction (MI)
Time frame: 1 year (non-inferiority)
co-primary TLR endpoint
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-year FU will be evaluated (efficacy endpoint - superiority)
Time frame: 2 Year FU
Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF)
Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected: 1. Death caused by acute MI 2. Death caused by sudden cardiac, including unwitnessed, death 3. Death resulting from heart failure 4. Death caused by stroke 5. Death caused by cardiovascular procedures 6. Death resulting from cardiovascular hemorrhage 7. Death resulting from other cardiovascular cause Any MI not clearly attributable to a non-target vessel will be considered as target-vessel MI. * Percutaneous coronary intervention (PCI) related MI is termed type 4a MI. * Coronary artery bypass grafting (CABG) related MI is termed type 5 MI. Revascularization is clinically driven if the target lesion diameter stenosis is \> 50% by quantitative coronary angiography (QCA) and the subject has clinical or functional ischemia which cannot be explained by another native coronary or bypass graft lesion.
Time frame: 1 year FU
Bleeding
Bleeding BARC 2 or greater
Time frame: 2 year
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Dhaka, Bangladesh
Antwerp Cardiovascular Center Middelheim
Antwerp, Belgium
UZ Leuven
Leuven, Belgium
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
INSTITUTO DO CORAÇÃO - InCor University of São Paulo Medical School
São Paulo, Brazil
...and 80 more locations