Shanghai, China, 24 October 2021 — Researchers met remotely in a recent teleconference for the TARGET PREMIER project, a pre-market clinical study on the next-generation rapamycin target eluting coronary stent initiated by Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") and led by Prof. Zhixiong Zhong from the Meizhou People’s Hospital, who serves as the Project’s principal investigator. The conference was chaired by Mr. Ming Zheng, Senior Vice President of Clinical Medicine at MicroPort®. Researchers and experts from relevant medical departments of nearly 10 centers across China joined the conference.
The TARGET PREMIER study is a prospective, multicenter, and single-arm clinical trial designed to evaluate the safety and efficacy of the rapamycin target eluting stent system for the treatment of de novo coronary artery stenosis. The study is expected to enroll a total of 200 subjects with de novo coronary artery stenosis. The primary endpoint of the study is in-stent late lumen loss at nine months after the index procedure, while secondary endpoints include target lesion failure, incidence of target lesion, target vessel revascularization, and stent thrombosis during five years follow-up.
During the conference, Mr. Ming Zheng introduced the development history of MicroPort® to the participating researchers and experts, and shared the latest progress and data from global clinical trials on the rapamycin target eluting stent family of products. The Firehawk® Stent, a drug-eluting stent (DES) independently developed by MicroPort®, is the world's first DES that of abluminal grooves and provides the controlled and targeted release of the drug into the vessel wall. It combines the advantages of the bare metal stent and drug-eluting stent. Almost 600 grooves are evenly cut in the strut of Firehawk®, which is made of hair-thin and extremely hard CoCr alloy. The drug is precisely loaded into the micro grooves by fully automated 3D printing and groove-filling techniques. The Firehawk® Stent is able to achieve “golden standard” efficacy at the world’s lowest dosage—only one-third that of similar products, resulting in significant safety improvements. The next-generation rapamycin target eluting stent used in this clinical trial is the third generation of the Firehawk® family. Compared with its predecessors, the new Firehawk® features an optimized platform pattern and dimensions. While maintaining the world-leading advantages of Firehawk® in terms of minimum drug loading and minimum polymer content, the third-generation Firehawk® further reduces the thickness of the stent. Combining the safety of a metal stent and the efficacy of a drug-eluting stent, it allows for faster endothelialization and reduced thromboembolic events and restenosis.
Opening remarks were given by Prof. Zhixiong Zhong, the principal investigator, and Prof. Ping Li, the co-principal investigator from the Yulin First People’s Hospital. Prof. Zhong also introduced the design of the TARGET PREMIER study and explained in detail the inclusion and exclusion criteria, the trial process, medication requirements, and informed consent regarding the trial. Prof. Zhong commented, “The MicroPort® Firehawk® stent has shown favorable performance in clinical practices. The stent used in the TARGET PREMIER study adopts the same technology of strut in-groove coating for targeted drug delivery through an optimized stent structure. I believe this clinical study will be completed successfully and provide clinicians with new options for coronary interventions.” Prof. Li said, “MicroPort® coronary drug stents have been widely used in clinical practice. I hope that the new rapamycin target eluting stent can offer more benefits to patients. I also look forward to the results of this clinical study, which will add research value to clinical practice. ”
Mr. Ming Zheng also shared other clinical research programs and strategic global clinical research engagements in the field of cardiovascular disease treatment that MicroPort® is progressively developing. Backed by a wealth of clinical research data, MicroPort® aims to continuously diversify its cardiovascular interventional product portfolio and provide patients with more quality and affordable total solutions.