A Prospective, Multicenter, Single-arm, Target-Value Clinical Trial to Evaluate the Safety and Efficacy of BM Shockwave Devices to Treat Coronary Calcified Lesions
This clinical trial is a prospective, multicenter, single-arm, target-value study to verify the safety and efficacy of BM coronary shockwave devices for the treatment of coronary calcification lesions.
• General inclusion criteria:
∙ Age 18-85 years, male or female;
‣ Patients with evidence of asymptomatic ischemia, stable or unstable angina, or old myocardial infarction;
‣ Patient is able and willing to comply with all assessments in the study.
• Angiography inclusion criteria:
⁃ The target lesion is a de novo, in-situ coronary artery lesion;
⁃ The target lesion length is ≤40 mm, and the target lesion reference vessel diameter is 2.0-4.0 mm (visual estimation);
⁃ The target lesion diameter stenosis is visually estimated to be ≥70%, or \<70% but ≥50% with evidence of ischemia;
⁃ Clear high-density calcification shadows are visible both during cardiac contraction and at rest;
⁃ Target vessel TIMI flow grade 3 prior to use of the investigational device (pre-dilatation is permitted);
⁃ The target lesion is the only calcified lesion to be treated with shock wave therapy in this session; if non-target lesions are present, they must be successfully treated prior to the target lesion;
⁃ Patients suitable for treatment with metal stent implantation.