BM Shockwave Devices Clinical Study in Coronary Calcified Lesions

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT07010094
• Lead Sponsor: BrosMed Medical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-28
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Study Start: 2025-06-15
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Procedure success rate	Endpoints will be measured through hospital discharge (expected to be within 7 days)	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.

Secondary Outcome Measures

Name	Time	Method
Angiography success rate	0 day	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.
Residual stenosis	0 day	Degree of residual stenosis immediately after shockwave pretreatment of the target lesion.
Device success rate	0 day	The study device successfully passes through the target lesion, and no serious angiographic complications occur immediately after shockwave pretreatment.
MACE rate	30 days	MACE is defined as cardiac death, myocardial infarction, and target vessel revascularization events.
Target lesion failure	30 days	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.
Device defects	0 day	Incidence of device defects

Trial Locations

Locations (1)

Xiamen University Affiliated Cardiovascular Hospital; 🇨🇳 Fujian, Xiamen, China