TARGET II, a prospective, multicenter, single-arm, observed registered clinical trial of Firehawk Raparmacyin Target Eluting Coronary Stent System sponsored by MicroPort Medical (Shanghai) Co., Ltd, completed the patient enrollment process on Feb 13th, 2012. To date, all patient enrollments for the pre-marketing clinical study of Firehawk have been achieved. The clinical study has now entered the clinical follow-up and data-processing stage.
There are three phases in Firehawk pre-marketing clinical investigation study: FIM (First-In-Man), TARGET I and TARGET II. The patient recruitment of FIM was completed in January 2010. 4-month OCT follow-up, 4- and 13-month angiographic follow-ups and 12-month clinical follow-up were then sequentially completed. TARGET I was a prospective, multicenter, randomized controlled clinical trial of Firehawk. The patient enrollment of Target I was completed in May, 2011 and the result of a 9-month angiographic follow-up and 12-month clinical follow-up will be published at TCT2012.
There were a total of 1,261 patents been enrolled in the pre-marketing clinical investigation of Firehawk in China. The clinical trial is a milestone, as it is the first-ever trail in compliance with the SFDA's guidance on Drug-Eluting Coronary Stents Systems:-Clinical Studies (Draft). It is also the largest clinical study on drug eluting coronary stent systems that ever been conducted in China.