Diabetes has been the Achilles heel for any vascular interventional procedures and there is a clinical need for adequately powered RCTs. The prospective, randomized, open-label, 2-arm parallel-group RCT has enrolled a mammoth 3050 diabetic patients. The RCT is steered by Prof. Roxana Mehran (Chairperson), Prof. Marie-Claude Morice (Medical Director), Prof. Alexandre Abizaid, Prof. Antonio Colombo & Prof. Shigeru Saito (Principal Investigators).
The primary endpoints of the planned RCT are TLF (composite of cardiac death, MI or ischemia-driven TLR) powered for non-inferiority and ischemia-driven TLR at 1- year FU powered for non-inferiority and sequential superiority for diabetic patients.
"In the face of the pandemic, the completion of enrollment of the ABILITY DM study marks an important milestone in the largest ever prospective randomized clinical trial in patients with Diabetes Mellitus. This signifies a crucial juncture in providing real-time and current evidence with Abluminus DES+ (with DCB) technology pitched against the best-in-class DES," reflected Roxana Mehran.
Prof. Antonio Colombo shares similar sentiments. "We completed enrollment of a landmark trial. The first trial comparing two different DES in 3050 diabetics. The results will be a benchmark for any new or old PCI technology," he said.
"I would like to thank all the site investigators, operators, technicians, and study coordinators, the Cardiovascular European Research Center (CERC), and Mount Sinai and ICAHN School of Medicine who played a stellar role in achieving this," exuded Prof. Marie-Claude Morice (CERC), "in particular the CERC and Mount Sinai research team who conducted the trial so well at such a complex time; their commitment is unique and will contribute to the success of the trial, a potentially significant improvement for Diabetic patients with cardiovascular disease".
Instituto Dante Pazzanese de Cardiologia (Brazil) led by Dr Daniel Chamie, and the National Heart Foundation Hospital & Research Centre (Bangladesh), led by Dr Fazila Malik, played a major role in completing the enrollment followed by OLVG (The Netherlands) led by Dr Maarten Vink.
Abluminus DES+ (Concept Medical Inc.), which has regulatory approvals in Europe and other countries, uses a proprietary Envisolution technology to provide homogenous drug delivery by coating the stent surface and exposed parts of the balloon and on the edges of the balloon. In clinical studies conducted at other centers Abluminus DES+ has proven effective in managing patients with DM.
Prof. Alexandre Abizaid, who has widely used the product, "I would like to congratulate Concept Medical and all the investigators for completing the largest randomized trial in PCI for diabetic patients. This 3000-patient trial tested a novel DES technology called Abluminus which is the combination of a Sirolimus eluting stent crimped on a drug coated balloon. This is certainly a landmark study in the modern era of complex coronary intervention".
About Concept Medical Inc (CMI):
CMI is headquartered in Tampa, Florida and has operational offices in The Netherlands, Singapore and Brazil and manufacturing units in India. CMI specializes in developing drug-delivery systems and has unique and patented technology platforms that can be deployed to deliver any drug / pharmaceutical agent across the luminal surfaces of blood vessels.