ClinACE Announces Commencement of CE Mark Registration Trial for a Coronary Stent
ClinACE Contract Research announced its foray into clinical research of Medical Devices. It has commenced working on a CE (European Conformity) mark registration trial for a coronary stent device. This new venture allows ClinACE to add operational diversity and continue to exhibit its expertise in the field of research.
The clinical trial is designed to evaluate safety of a drug eluting stent in patients with native coronary artery lesions. The clinical endpoint planned is Assessment of MACE, while Angiographic endpoint will include in stent late lumen loss, binary re-stenosis, and percentage diameter loss at six months follow up. The trial will be conducted on patients recruited across three different sites in India.
According to, 2011India Medical Device Updates*, India's medical device market is currently the fourth largest market in Asia and is worth about $3 billion. The fastest growing medical device segments are orthopedic, neurology cardiology and cosmetics/aesthetics. Though there have been very few medical device blockbusters in the past, cardiac devices have always been a runaway success. Despite the fact that device market is growing there are very few CRO’s in India that provide service for testing Class III (high-risk) medical devices.
“We are delighted to work on this project. The number of ongoing clinical trials on stents in India is very few. Most out of them are conducted by the sponsor themselves and very few are outsourced to a CRO. It is indeed a very good opportunity to prove our ability in another sector of clinical research”, commented
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