Calcification of Coronary Artery Clinical Trial
Official title:
A Prospective, Multicenter Clinical Trial of Coronary Atherectomy System in Patients With Calcified Coronary Artery Lesion
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary atherectomy system for the treatment of patients with coronary calcification.
This study is divided into two phases. The first phase is the pilot study stage, which is a prospective single group observational test (FIM stage). The second phase is the pivotal study phase, which is a prospective, multicenter, randomized controlled and non inferiority test (RCT phase). It is carried out in about 25 hospitals in China. 1. Pilot study phase (FIM phase): It is a prospective, multicenter and single-arm observational test. It is expected to recruit 15 subjects in 3 to 5 research centers in China. The primary endpoint is procedural success rate. 2. Pivotal study phase (RCT phase): It is a prospective, multicenter, randomized controlled and non inferiority trial. 224 subjects are expected to be recruited in 25 research centers in China and randomly divided into two groups according to the ratio of test group: control group = 1:1. The primary endpoint of the RCT phase is the rate of no major adverse cardiovascular events (MACE) at 30 days after baseline. 3. All subjects with coronary calcified lesions participating in this clinical study must have a calcified lesion length of no more than 40 mm and located in an coronary artery with a diameter of ≥ 2.50 mm but ≤ 4.00 mm. 4. All subjects receive clinical follow-up during hospitalization and 30 days, 6 months and 12 months after surgery. 5. Successful enrollment: The atherectomy guidewires pass through the target lesion successfully (through the true lumen), and there are no vascular perforation, dissection, thrombosis and other complications. ;