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Post-Marketing Clinical Study of High-Pressure Cutting Balloon
Sponsor: BrosMed Medical Co., Ltd
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
Conditions
Interventions
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.
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