ABILITY Diabetes Global (Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents versus Everolimus-Eluting Stents in Coronary Artery Disease Patients with Diabetes Mellitus Global) started off with the index patient enrolment on 11th June 2020 in Italy (at the peak of the 1st wave of COVID-19 pandemic) by P.I. Prof. Antonio Colombo and the pace of enrolment since then has been steady and consistent, with a thousand patients being enrolled in just over a year.
Despite COVID-19 ravaging world over, the pace of enrolment is remarkable considering the fact that the healthcare facilities are occupied in caring for patients hospitalized with COVID-19. Although COVID-19 crisis still looms over us, Cardiovascular Disease (CVD) remains the number one killer and Diabetes continues to be the key comorbidity and contributor to Coronary Artery Disease (CAD).
ABILITY Diabetes Global is the world’s largest Randomized Controlled Trial (RCT) for CAD patients with diabetes as a comorbidity. This RCT measures the safety and efficacy of the Abluminus DES+ which is specially crafted with the patented Envisolution Technology and has proven to be effective in managing the proliferative CAD lesions seen in DM.
With the promising pace of enrolment so far, Concept Medical eagerly looks forward to the completion and results of ABILITY Diabetes Global targeting more than 3000 diabetic patients, across 100 centres, spanning more than 25 countries against the XIENCE EES family (Abbott Cardiovascular).
Concept Medical is delighted to be a part of this achievement which is a direct result of endless support, guidance, and experience of Prof. Roxana Mehran (Chairperson), Prof. Marie-Claude Morice (Medical Director), Prof. Alexandre Abizaid, Prof. Antonio Colombo & Prof. Shigeru Saito (Principal Investigators), and the entire steering committee. Contributing to this achievement are the sites who showed encouragement in participation with the top enrollers so far being – Instituto Dante Pazzanese, Sao Paulo, Brazil (Dr. Chamié), National Heart Foundation Hospital and Research Institute, Dhaka, Bangladesh (Prof. Malik), Herzzentrum Segeberger Kliniken, Bad Segberg, Germany (Dr. Allali) and many more. It is the dedication and commitment of all the sites, the site investigator, and technicians for accomplishing this. The credit also extends to Cardiovascular European Research Center (CERC), Mount Sinai and ICAHN School of Medicine for their valuable contribution and constant coordination every day which is of utmost importance.
At this point, when the trial is proceeding with excellent engagement from its investigators, and coordinators. Prof. Mehran expresses her enthusiasm, “I am encouraged by the progress we are making on this largest trial in PCI and Diabetes and incredibly enthusiastic about the future of what we can offer to these complex patients with progress in innovation in PCI.”
Prof. Marie-Claude Morice, CEO of CERC expresses her thoughts, “The CERC team is pleased to work hand in hand with the Mount Sinai and the Concept Medical team. We are extremely proud to achieve this important milestone. This study is significant for Diabetic patients with coronary disease who continue to be treated sub optimally with current devices. The ‘non-COVID’ patients should not be ignored during pandemic period. Thanks to the highly motivated investigators and study coordinators, we were able to obtain consent from the respective ethics committees which enabled us to enroll 1000 patients at such a fast pace.”
For a company with the vision of Advancing Innovation, the 1000 patient enrolment is a significant milestone towards a possible breakthrough in the medical device industry. Concept Medical looks to progress rapidly and add one more milestone to its credit.