To provide a better angioplasty technique for patients suffering from coronary artery disease AIIMS to conduct clinical study
All India Institute of Medical Education (AIIMS) is recruiting patients for a clinical study to evaluate a new nanotechnology based Drug-Eluting Stent (DES) for opening of narrowed arteries of the heart. The study, to find better stent design and delivery, a safer drug, and more inert platforms for drug release, is based on hypothesis that a new stent made of nanoporous particle with better polymer for drug release will prove to be safer and more efficacious alternative to currently available DES.
The clinical and angiographic evaluation project on paclitaxel eluting, non-polymeric, nanoporous, cobalt-chromium stent is tested through non-randomized, open label, safety and efficacy study, according to reports. This project commenced in January 2007 is expected to be completed by October 2007.
The study will be carried out in 200 subjects and the institute will come out with the result after publishing the project details on an international journal.
Drug eluting stents, currently in market are still prone to narrowing in high-risk patients and have a higher chance of late thrombosis.
The study is an effort to develop technology for more efficacious and safer DES, according to the data provided by AIIMS.
The study on various doses of paclitaxel, aimed to evaluate the response of porcine coronary arteries to the novel nano-polymeric stent, showed acceptable performance characteristics, with respect to endothelialization, neointimal hyperplasia, percentage diameter stenosis, inflammatory response, and tendency to fibrin deposition, when compared to historical data with the Cypher stent.
The study will also focus on the issues of late complications occurring through the indefinite presence of polymer thought to initiate and sustain inflammation, demonstrated the safety and efficacy of the novel device.