NCT07010094 BM Shockwave Devices Clinical Study in Coronary Calcified Lesions
| NCT ID | NCT07010094 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BrosMed Medical Co., Ltd |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 198 participants |
| Start Date | 2025-06-27 |
| Primary Completion | 2026-07-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * General inclusion criteria: 1. Age 18-85 years, male or female; 2. Patients with evidence of asymptomatic ischemia, stable or unstable angina, or old myocardial infarction; 3. Patient is able and willing to comply with all assessments in the study. Angiography inclusion criteria: 1. The target lesion is a de novo, in-situ coronary artery lesion; 2. The target lesion length is ≤40 mm, and the target lesion reference vessel diameter is 2.0-4.0 mm (visual estimation); 3. The target lesion diameter stenosis is visually estimated to be ≥70%, or \<70% but ≥50% with evidence of ischemia; 4. Clear high-density calcification shadows are visible both during cardiac contraction and at rest; 5. Target vessel TIMI flow grade 3 prior to use of the investigational device (pre-dilatation is permitted); 6. 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