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Clinical Trial Summary

The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world. The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm.


Clinical Trial Description

Study Design: 1. Prospective, international multi-center clinical study; 2. It is planned to recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions; 3. In the study, subgroups of long lesions, bifurcation lesions, and acute myocardial infarction were set up, and subjects who met the definition were directly entered into the subgroup analysis. 4. Register and collect data using the EDC system; 5. Enrollment method: competitive enrollment; 6. Follow-up time points: postoperative to before discharge, 30 days, 6 months, 12 months, and 24 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06385067
Study type Observational
Source JW Medical Systems Ltd
Contact Yuanchun Sun
Phone 13683382463
Email sunyuanchun@bluesail.cn
Status Not yet recruiting
Phase
Start date May 10, 2024
Completion date December 30, 2026

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