RecruitingNot Applicable

BM Shockwave Devices Clinical Study in Coronary Calcified Lesions

China198 participantsStarted 2025-06-27

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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);

Exclusion criteria

✕. 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;

What they're measuring

Procedure success rate

Timeframe: Endpoints will be measured through hospital discharge (expected to be within 7 days)

Trial details

NCT IDNCT07010094

SponsorBrosMed Medical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-01

Contact for this trial

Wang Yan, Professor

0592-968120 wy@medmail.com.cn

View on ClinicalTrials.gov More Coronary Artery Disease trials