BM Shockwave Devices Clinical Study in Coronary Calcified Lesions

NCT07010094 | Recruiting

• 1 other identifier: D24
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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

Keywords

Coronary artery disease; shockwave therapy; Coronary calcified lesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Angiography success rate

  0 day

• Device success rate

  0 day

• Residual stenosis

  0 day

• MACE rate

  30 days

• Target lesion failure

  30 days

Study Arms (1)

Test group

EXPERIMENTAL

Device: BM shockwave devices

Interventions

BM shockwave devices DEVICE

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

Test group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• ST-segment elevation myocardial infarction within 3 days prior to the procedure;
• Use of rotational atherectomy or special balloons (chocolate balloon, scoring balloon, cutting balloon, etc.) for lesion pretreatment;
• New York Heart Association (NYHA) functional class III or IV;
• Target lesion expected to require full biodegradable scaffold implantation, drug-eluting balloon dilation, or percutaneous transluminal coronary angioplasty (PTCA) treatment;
• Uncontrolled severe hypertension (persistent: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg);
• 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;
• Platelet count \<60 × 10⁹/L;
• Stroke within the past 6 months prior to enrollment, excluding transient ischemic attack (TIA) and lacunar infarction;
• Active peptic ulcer or history of upper gastrointestinal bleeding within the past 6 months prior to enrollment;
• Known allergy to heparin, contrast agents, aspirin, clopidogrel, or anesthetics;
• Patients with a life expectancy of less than 12 months due to severe medical conditions;
• Patients who have participated in other drug or device clinical trials and failed to meet the primary endpoint;
• Pregnant or breastfeeding women;
• Patients deemed by the investigator to have poor compliance and unable to complete the study according to the protocol.
• The target lesion and non-target lesion are in the same vascular branch;

Sponsors & Collaborators

• BrosMed Medical Co., Ltd: lead

Study Sites (1)

Xiamen University Affiliated Cardiovascular Hospital

Fujian, Xiamen, 361000, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Wang Yan, Professor

CONTACT

0592-968120; wy@medmail.com.cn

Wang Yan

CONTACT

0592-968120; wy@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 8, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)