Country for PR: United Kingdom
Contributor: PR Newswire Europe
Wednesday, September 28 2022 - 22:47
ABILITY DIABETES GLOBAL – A Landmark RCT in the field of PCI for patients with DM, completes Enrolment
TAMPA, Fla., Sept. 28, 2022 /PRNewswire- AsiaNet/-

 is the World's largest Randomized Controlled Trial (RCT) for patients with DM 
(Diabetes Mellitus), comparing head-to-head the Sirolimus eluting stent , 
Abluminus DES+ (Concept Medical Inc.[]) with the 
XIENCE family of DES (Abbott Cardiovascular).

    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 Chamié, 
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 


    Source: Concept Medical Inc.