Beijing, China – On August 10, during the China Heart Congress, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") hosted the First Investigator Meeting for the pivotal clinical study TARGET CTO Trial of Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®") in the complex lesion. Around 20 investigators from 10 sites attended the meeting.
The TARGET CTO Trial is a prospective, multi-center, randomized clinical trial in the complex CTO lesion. A total of 196 patients will be enrolled up to 15 sites in China. The subjects will be randomized 1:1 into Firehawk® group or Abbott Xience family everolimus eluting stents group. The primary endpoint of the trial is QCA 12-month in-stent late loss, and the secondary OCT endpoint is stent neointimal thickness at three months and 12 months by OCT. The patient enrolled in TARGET CTO trial will continue follow-up to five years.
The meeting was chaired by Ming Zheng, Vice President of Clinical Science & Medical Affairs and President of MicroPort® Knowledge & Action Institute. During the meeting, MicroPort® Chief Marketing Officer Bo Peng and the Principal Investigator Professor Yaling Han of the General Hospital of Shenyang Military, who is also the academician of Chinese Academy of Engineering, delivered speeches respectively on behalf of MicroPort® and the investigators. Then, Ming Zheng introduced the global clinical study programs of Firehawk® - since the launch of TARGET FIM in 2009 following the first patient enrollment, the TARGET series studies enlarged its coverage from China to Europe, Southeast Asia, North America, and South America with nearly 16,000 patients enrolled in this large-scale global clinical studies. The latest clinical outcome released include the five-year follow-up data of TARGET I RCT which showed the stent thrombus rate is zero, and the data of the OCT substudy clinical of TARGET AC involving 21 hospitals in 10 European countries which showed the three-month stent strut cover rate was of 99.9%, demonstrating early vessel healing and excellent long-term safety and efficacy of Firehawk®.
Professor Yaling Han introduced the protocol of TARGET CTO study, including its background, design rationale, Firehawk® stent radial force bench test, the inclusion and exclusion criteria, pre-, intra- and post-operative medication requirements, the stage definition for CTO with multi vessel lesions and pre-defined intercurrent follow-up angiography. She discussed about these details with the investigators in attendance and emphasized on GCP principle and the importance to protect patients enrolled in the study. In the end, Dr. Sining Hu of the Second Affiliated Hospital of Harbin Medical University, which represents the independent OCT core lab, and experts from CRO radiography core lab respectively presented the OCT and QCA protocol and Guideline to ensure that the core data of the study are reliable, complete and continuous.
"MicroPort® is the first domestic company independently develops and manufactures products used in coronary interventional treatment. As the leading coronary medical device provider in China, MicroPort® rapidly develops to a global medical device company within 20 years and its third-generation Firehawk® offers ideal solution for complex lesions," Professor Han said. "As the principal investigator of TARGET CTO study, I'm looking forward to completing patient enrollment and releasing outcome of the study. CTO is the last bastion of interventional therapy for coronary artery disease, so the TARGET CTO trial is extremely challenging clinical study program. The existing data show that Firehawk® have fast and ideal vessel healing results, and this advantage should be attributed to Firehawk®'s innovative abluminal groove design and the absorbing polymer coating, which is of far-reaching significance to treat CTO and other complex lesions, as it can effectively reduce the potential late adverse events. We are looking forward to seeing such advantages proved in the following high-quality clinical trial programs."
"We are glad to see that Firehawk® TARGET series global clinical program is carried forward smoothly as scheduled, and we have exciting clinical follow-up outcome from both the China market and the relatively matured European market," stated Ming Zheng, Vice President of MicroPort® Clinical Science & Medical Affairs and President of MicroPort® Knowledge & Action Institute. "We hope the results of the primary end point for 12-month clinical follow-up (target lesion failure) and substudy 13-month angiographic follow-up for Firehawk® TARGET AC that reflects the European real world practice will be released next year as scheduled, to further demonstrate the safety and efficacy of Firehawk®."
MicroPort® will continue to advance the robust series clinical research program globally, including the TARGET DAPT Trial and TARGET SAFE Trial short-range dual antiplatelet therapy programs that will be respectively launched in the near future to evaluate the safety and effectiveness for the routine and high bleeding risk in patients undergoing percutaneous coronary intervention ("PCI") treatment with Firehawk® and with short double antibody therapy compared to the routine double antibody treatment. With the support of increasingly more clinical data, Firehawk® is demonstrated to have the potential to reduce the duration of dual antiplatelet therapy after stent implantation, lower the risk of bleeding from long-term dual antiplatelet therapy in patients with high bleeding risk, and cut the medical costs, to bring benefit to more patients with coronary heart diseases worldwide.