Clinical Trial: Post-Marketing Clinical Study of High-Pressure Cutting Balloon

U.S., Sept. 23 -- ClinicalTrials.gov registry received information related to the study (NCT07835178) titled 'Post-Marketing Clinical Study of High-Pressure Cutting Balloon' on Sept. 17.

Brief 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. ...