BM Shockwave Devices Clinical Study in Coronary Calcified Lesions

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: BM shockwave devices

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang Yan, Professor; Phone Number: 0592-968120; Email: wy@medmail.com.cn
• Study Contact Backup: Name: Wang Yan; Phone Number: 0592-968120; Email: wy@medmail.com.cn

Study Locations

• China
  • Xiamen
    • Fujian, Xiamen, China, 361000
      • Recruiting
      • Xiamen University Affiliated Cardiovascular Hospital
      • Contact: Wang Yan, Ph.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group	Device: BM shockwave devices; Use the BM shockwave devices for pre-treatment of coronary calcification lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure success rate	Definition: Residual stenosis ≤30% after PCI, and no major adverse cardiac events (MACE) events occurring during hospitalization. MACE is defined as cardiac death, myocardial infarction, and target vessel revascularization events.	Endpoints will be measured through hospital discharge (expected to be within 7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiography success rate	Definition: After successful stent placement in the target lesion, residual stenosis ≤ 30%, and no serious angiography complications occur. Serious angiography complications: refer to the occurrence of D-F type dissection, vascular perforation, acute vascular occlusion, persistent slow blood flow, or no reperfusion during the procedure.	0 day
Device success rate	The study device successfully passes through the target lesion, and no serious angiographic complications occur immediately after shockwave pretreatment.	0 day
Residual stenosis	Degree of residual stenosis immediately after shockwave pretreatment of the target lesion.	0 day
MACE rate	MACE is defined as cardiac death, myocardial infarction, and target vessel revascularization events.	30 days
Target lesion failure	Target lesion failure (TLF) definition: Includes cardiac death, myocardial infarction caused by target vessel (ST-segment elevation or non-ST-segment elevation myocardial infarction), and target lesion revascularization.	30 days
Device defects	Incidence of device defects	0 day

Collaborators and Investigators

• Sponsor: BrosMed Medical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 28, 2025
• First Submitted That Met QC Criteria: June 4, 2025
• First Posted (Actual): June 8, 2025

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Coronary artery disease; shockwave therapy; Coronary calcified lesions
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: D24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No