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RECRUITING
NCT07835178
NA

Post-Marketing Clinical Study of High-Pressure Cutting Balloon

Sponsor: BrosMed Medical Co., Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2026-09

Completion Date

2028-12

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

DEVICE

High pressure cutting balloon

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

DEVICE

Non-cutting balloon

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

Locations (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China