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NCT04236609 Clinical Trial

Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global

Coronary Artery Disease Clinical Trial

— ABILITY  

Official title:
ABILITY Diabetes Global

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04236609
Other study ID # COMED.CT.DES.001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 15, 2020
Est. completion date September 30, 2024

Study information
Verified date March 2023
Source Concept Medical Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

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Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Abluminus DES+ Sirolimus Eluting Stent System (SES)
The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical
• XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA
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Sponsors (1)
Lead Sponsor Collaborator
Concept Medical Inc.

Countries where clinical trial is conducted

Australia,  Austria,  Bangladesh,  Belgium,  Brazil,  Czechia,  France,  Germany,  India,  Ireland,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Poland,  Singapore,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

References & Publications (26)

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Outcome
Type Measure Description Time frame Safety issue
Other Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF) Cardiovascular death is defined as death resulting from cardiovascular causes. Any MI not clearly attributable to a non-target vessel will be considered as target-vessel 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.		 2 year FU
Other Occurrence of cardiovascular death and target-vessel myocardial infarction (MI) Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected:
Death caused by acute MI
Death caused by sudden cardiac, including unwitnessed, death
Death resulting from heart failure
Death caused by stroke
Death caused by cardiovascular procedures
Death resulting from cardiovascular hemorrhage
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.		 2 year
Other All-cause mortality all deaths are considered cardiovascular unless an alternate cause is unequivocally established, even among subjects with serious noncardiac comorbidities. up to 2 years from procedure
Other Stroke according to Neuro-ARC stroke/TIA criteria up to 2 years from procedure
Other Stent thrombosis defined for grade and timing according to the Academic Research Consortium2 2 year
Other Technical success Technical success is defined as the ability to cross the occluded segment with both a wire and a balloon, and successfully open the artery; the restoration of antegrade TIMI flow 2 or 3 and a <30% residual stenosis. (As applies to chronic total occlusion - CTO - lesions) 2 year
Other Clinical procedural success In the case of percutaneous intervention for obstructive lesions, procedural success is defined as the achievement of a final residual diameter stenosis < 30% by angiography at the end of the procedure (and without flow limiting arterial dissection and hemodynamically significant translesional pressure gradient) without any in-hospital major adverse events (death, acute onset of limb ischemia, need for urgent/emergent vascular surgery). The balloon inflation and/or stent placement may be preceded by use of adjunctive devices (e.g., percutaneous mechanical thrombectomy, directional or rotational atherectomy, laser, chronic total occlusion crossing device).
Ideally, the assessment of the residual stenosis at the end of the procedure should be performed by an angiographic core laboratory.		 2 year
Other Occurrence of ischemia-driven TLR 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. 2 year FU
Other Target vessel revascularization (TVR) TLR is a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. up to 2 years
Primary Rate of Ischemia-driven TLR powered for non-inferiority and sequentially superiority 1 year FU
Primary Rate of Target lesion failure TLF composite of cardiovascular death, target vessel myocardial infarction [MI], or ischemia driven target lesion revascularization [idTLR]) 1 year FU, powered for non-inferiority
Secondary Safety composite endpoint Safety composite endpoint of the occurrence of cardiovascular death and target-vessel myocardial infarction (MI) 1 year (non-inferiority)
Secondary 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) 2 Year FU
Secondary 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:
Death caused by acute MI
Death caused by sudden cardiac, including unwitnessed, death
Death resulting from heart failure
Death caused by stroke
Death caused by cardiovascular procedures
Death resulting from cardiovascular hemorrhage
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.		 1 year FU
Secondary Bleeding Bleeding BARC 2 or greater 2 year
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