BM Shockwave Devices Clinical Study in Coronary Calcified Lesions

NCT ID: NCT07010094

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-27
• Study Completion Date: 2026-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test group

Group Type: EXPERIMENTAL

BM shockwave devices

Intervention Type: DEVICE

Use the BM shockwave devices for pre-treatment of coronary calcification lesions.

Interventions

BM shockwave devices

Use the BM shockwave devices for pre-treatment of coronary calcification lesions.

Intervention Type: DEVICE

Eligibility Criteria

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.

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 to the target lesion;

7. Patients suitable for treatment with metal stent implantation.

Exclusion Criteria

1. ST-segment elevation myocardial infarction within 3 days prior to the procedure;

2. Use of rotational atherectomy or special balloons (chocolate balloon, scoring balloon, cutting balloon, etc.) for lesion pretreatment;

3. New York Heart Association (NYHA) functional class III or IV;

4. Target lesion expected to require full biodegradable scaffold implantation, drug-eluting balloon dilation, or percutaneous transluminal coronary angioplasty (PTCA) treatment;

5. Uncontrolled severe hypertension (persistent: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg);

6. Severe liver or kidney dysfunction, with transaminase levels exceeding three times the upper limit of normal, serum creatinine >2.5 mg/dL (221 μmol/L), or chronic kidney failure requiring long-term dialysis;

7. Platelet count <60 × 10⁹/L;

8. Stroke within the past 6 months prior to enrollment, excluding transient ischemic attack (TIA) and lacunar infarction;

9. Active peptic ulcer or history of upper gastrointestinal bleeding within the past 6 months prior to enrollment;

10. Known allergy to heparin, contrast agents, aspirin, clopidogrel, or anesthetics;

11. Patients with a life expectancy of less than 12 months due to severe medical conditions;

12. Patients who have participated in other drug or device clinical trials and failed to meet the primary endpoint;

13. Pregnant or breastfeeding women;

14. Patients deemed by the investigator to have poor compliance and unable to complete the study according to the protocol.

1. The target lesion and non-target lesion are in the same vascular branch;

2. The target lesion is at the origin (LAD, LCX, or RCA, within 5 mm of the origin) or an unprotected left main lesion;

3. A stent has been implanted within 10 mm of the proximal or distal end of the target lesion;

4. The target lesion has an unprotected branch vessel with a diameter of 2.5 mm or greater;

5. The target lesion is located distal to the saphenous vein or LIMA (left internal mammary artery)/RIMA (right internal mammary artery) bypass graft;

6. An aneurysm is present within 10 mm of the target lesion;

7. Contrast imaging confirms the presence of an NHLBI classification D-F type arterial dissection at the target lesion prior to the use of the investigational device;

8. The target lesion has definite thrombus formation;

9. The investigator determines that the target lesion is not suitable for vascular dilation in the patient.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BrosMed Medical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiamen University Affiliated Cardiovascular Hospital

Fujian, Xiamen, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Yan, Professor

Role: CONTACT

wy@medmail.com.cn

0592-968120

Wang Yan

Role: CONTACT

wy@medmail.com.cn

0592-968120

Facility Contacts

Wang Yan, Ph.

Role: primary

Other Identifiers

D24

Identifier Type: -

Identifier Source: org_study_id