BM coronary shockwave treatment for calcified coronary artery blockages

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 will test whether BM coronary shockwave devices can safely and effectively widen heavily calcified coronary arteries in adults with coronary artery disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 198 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: BrosMed Medical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Fujian, Xiamen)
• Trial ID: NCT07010094 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, multicenter device study using BM coronary shockwave technology during percutaneous coronary intervention to treat heavily calcified, de novo coronary lesions. Eligible adults undergo shockwave therapy targeted to a single calcified lesion (≤40 mm, vessel 2.0–4.0 mm) with pre- and post-procedure angiographic and clinical follow-up. The study tracks immediate procedural outcomes, device-related complications, and short-term clinical and imaging measures of artery opening and stent deployment. Data will be used to verify the safety profile and effectiveness of the BM device in this specific lesion population.

Who should consider this trial

Good fit: Adults 18–85 with coronary artery disease (stable/unstable angina or prior MI) who have a single de novo, heavily calcified coronary lesion of appropriate size (≤40 mm length, 2.0–4.0 mm vessel) and TIMI 3 flow are ideal candidates.

Not a fit: Patients with multiple calcified lesions to be treated in the same session, lesions outside the specified size or vessel range, poor distal flow, or non-calcified blockages are unlikely to benefit from this specific procedure.

Why it matters

Potential benefit: If successful, this device approach could make it easier and safer to break up coronary calcium, improving stent expansion and blood flow in patients with heavily calcified lesions.

How similar studies have performed: Similar intravascular shockwave (lithotripsy) approaches have shown promising results in improving stent expansion in calcified coronary lesions, though this specific BM device is being tested separately.

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 to the target lesion;
7. Patients suitable for treatment with metal stent implantation.

Exclusion Criteria:

* General 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.

Contrast exclusion criteria:

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.

Where this trial is running

Fujian, Xiamen

• Xiamen University Affiliated Cardiovascular Hospital — Fujian, Xiamen, China (Recruiting)

Study contacts

• Study coordinator: Wang Yan, Professor

Conditions Coronary Artery Disease; Coronary artery disease; shockwave therapy; Coronary calcified lesions