ABILITY DIABETES GLOBAL
Research type
Research Study
Full title
Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents versus Everolimus-Eluting Stents in Coronary Artery Disease Patients with Diabetes Mellitus (ABILITY Diabetes Global)
IRAS ID
268803
Contact name
David HILDICK-SMITH
Contact email
Sponsor organisation
Concept Medical Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
Diabetes mellitus (DM) is a growing global public health problem. Some 415 million people worldwide or one in eleven adults are estimated to have DM. If the current trend in diabetes prevalence continues, by 2040 some 642 million people, or one adult in ten, will have diabetes.
Patients with DM are more affected by coronary artery disease and when treated by coronaty angioplasty with stent implantation they remain at higher risk for in-stent restenosis and adverse cardiovascular events even in the drug-eluting stent (DES) era.This is a prospective, multicenter, multinational, randomized, open-label, 2-arm parallel groups that will include 3000 subjects at about 100 study sites in Europe, Asia, Latin America and Australia. Included patients will present diabetes mellitus and are scheduled to undergo a coronary angioplasty for one or more narrowing(s) in the coronary arteries. Once included in the study, the patient will receive either Abluminus DES+ sirolimus-eluting stents (SES) or Everolimus-Eluting Stents (EES) and will be followed for two years.
The purpose of the study is to compare in diabetic patients the efficacy and safety of these two drug-eluting stents used for coronary artery narrowing treatment.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
20/LO/0158
Date of REC Opinion
17 Apr 2020
REC opinion
Further Information Favourable Opinion