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BM Shockwave Devices Clinical Study in Coronary Calcified Lesions

ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBrosMed Medical Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • BM shockwave devices

    Device

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

Treatment groups

198 Participants
are divided into 1 treatment group
Group A: Test groupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Endpoints will be measured through hospital discharge (expected to be within 7 days)

Secondary outcomes

1

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.

Time frame
0 day
2

Device success rate

The study device successfully passes through the target lesion, and no serious angiographic complications occur immediately after shockwave pretreatment.

Time frame
0 day
3

Residual stenosis

Degree of residual stenosis immediately after shockwave pretreatment of the target lesion.

Time frame
0 day
4

MACE rate

MACE is defined as cardiac death, myocardial infarction, and target vessel revascularization events.

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BrosMed Medical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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