A Prospective, Multicenter, Single-arm, Target-Value Clinical Trial to Evaluate the Safety and Efficacy of BM Shockwave Devices to Treat Coronary Calcified Lesions

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Xiamen University Affiliated Cardiovascular Hospital
RECRUITING
Fujian
Contact Information
Primary
Wang Yan, Professor
wy@medmail.com.cn
0592-968120
Backup
Wang Yan
wy@medmail.com.cn
0592-968120
Time Frame
Start Date: 2025-06-27
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 198
Treatments
Experimental: Test group
Related Therapeutic Areas
Sponsors
Leads: BrosMed Medical Co., Ltd

This content was sourced from clinicaltrials.gov