Shenyang, China, 6 November 2021 — A national investigator kick-off meeting for the ‘PROMISE-BIF study’ was recently held in Shenyang China. The PROMISE-BIF study is a pre-market clinical trial for the new coronary next-generation rapamycin coronary balloon catheter, developed by Shanghai MicroPort Medical (Group) Co., Ltd. (MicroPort®). Investigators and experts from clinical research departments of over 20 investigation sites across China attended the hybrid meeting.
The PROMISE-BIF study is a prospective, multicenter, randomized, controlled clinical study with a plan to enroll 236 subjects randomly divided on a 1:1 basis into the study and control groups. The primary endpoint is the nine-month lumen diameter stenosis of the target lesion side branch(%), with secondary endpoints including the nine-month in-segment late lumen loss of the target lesion side branch(mm), device/lesion success rate, revascularization and stent thrombosis rate. Subjects enrolled in this trial will be followed for two years. Academician Yaling Han serves as the principal investigator of the PROMISE-BIF study, and Prof. Quanmin Jing is the co-principal investigator.
At the meeting, Prof. Jing presented the features of the rapamycin coronary balloon catheter and the study protocol. He said, "The rapamycin coronary balloon catheter features a unique coating technology and polymer/excipient-free design. Tissue concentration can maintain for more than 28 days, and the catheter delivery time during the procedure can take up to 15 minutes. To patients, it will help to avoid the local inflammatory response caused by polymers. In addition, the long catheter delivery time will ease the doctors to complete the procedure.”
During the meeting, Academician Han and Prof. Jing discussed with the participants the implementation and progress of the PROMISE-BIF program in detail, including the exclusion criteria, intervention procedures, device operation, drug regimen and informed consent.
As the moderator of the meeting, Mr. Ming Zheng, Senior Vice President of Clinical Medicine at MicroPort®, also shared MicroPort®’s plan and global strategy for clinical research in the field of cardiovascular disease treatment. MicroPort® is currently conducting various clinical research programs around the world, which will provide enhanced clinical data to support the expansion of its cardiovascular interventional product portfolio and provide more quality and inclusive total solutions for patients with coronary artery disease.
Shanghai MicroPort Medical (Group) Co., Ltd. (MicroPort®), is a subsidiary of MicroPort Scientific Corporation (Group) Co., Ltd. (stock code: 00853.HK). As a leader in high-end medical solutions, MicroPort® places emphasis on the human dimension while integrating the pursuit of perfection and innovation into the corporate DNA. In the future, MicroPort® will continue to pursue an innovative, people-centered culture to provide patients and physicians around the world with high-end medical devices and integrated solutions.