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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07010094

Enrollment

198

Registered

2025-06-08

Start date

2025-06-27

Completion date

2026-12-31

Last updated

2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease, shockwave therapy, Coronary calcified lesions

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.

Interventions

DEVICEBM shockwave devices

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Contacts

Primary ContactWang Yan, Professor

wy@medmail.com.cn0592-968120

Backup ContactWang Yan