RecruitingNot ApplicableNCT07835178

Post-Marketing Clinical Study of High-Pressure Cutting Balloon

A Clinical Study of the High-Pressure Cutting Balloon for Interventional Treatment of Calcified Coronary Lesions

Sponsor

BrosMed Medical Co., Ltd

Enrollment

280 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease Calcification

Summary

This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation. Subjects will be randomized in a 1:1 ratio to the experimental group (n=140) or the control group (n=140). The primary endpoint is the MSA measured by IVUS immediately after the procedure, with the purpose of verifying the safety and efficacy of the high-pressure cutting balloon in optimizing stent implantation outcomes.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Age ≥18 years;
Patients with coronary artery disease who indicate IVUS-guided drug-eluting stent implantation;
Moderate-to-severe calcified lesions on coronary angiography;
Target lesion is a de novo lesion in a native vessel that has not received any prior interventional treatment;
Target vessel diameter of 2.5-4.0 mm, with guidewire crossing of the target lesion;
In patients with multiple lesions, only one lesion will be selected as the target lesion in this study. If target and non-target lesions are treated during the same procedure, the target and non-target lesions must be located in different vessel branches; furthermore, the non-target lesion must be treated first, and the target lesion may be treated only after successful revascularization of the non-target lesion without severe angiographic complications;
Provision of written informed consent.

Exclusion Criteria12

Life expectancy <1 year;
Cardiogenic shock or hemodynamic instability;
Left main coronary artery disease;
Chronic total occlusion;
Bifurcation lesions planned for a "two-stent strategy";
Active bleeding;
Known history of allergy to contrast media or metals;
Patients with a bleeding tendency, contraindications to antiplatelet or anticoagulant therapy, or inability to receive anticoagulation therapy;
New-onset stroke/transient ischemic attack within 6 months;
Pregnant or lactating women;
Left ventricular ejection fraction <25%, or NYHA functional class IV, or Killip class ≥2;
Non-target vessel revascularization within 30 days before randomization with complications.

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Interventions

DEVICEHigh pressure cutting balloon

Lesion preparation is carried out using the cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.

DEVICENon-cutting balloon

Lesion preparation is carried out using the non-cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.