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Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of a novel Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-lesion late lumen loss at 6 months after the procedure in Korean patients with coronary de novo lesions compared with a product of the same category (SeQuent® Please NEO).


Clinical Trial Description

In a randomized controlled trial to compare with the same-category drug device (SeQuent® Please NEO), 204 patients with coronary de novo lesions were recruited from a total of 12 institutions, and the enrolled subjects were 1: 1 through randomization. The ratio was assigned to the test group and the control group, and each of the test or control devices was assigned to receive the procedure. The primary end point is the in-lesion late lumen loss of the target lesion at 6 months after the procedure, and the secondary end point is the target vessel failure (Composite of cardiac death, TV-MI, and ID-TVR) at 6 and 12 months after the procedure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05096442
Study type Interventional
Source Genoss Co., Ltd.
Contact
Status Completed
Phase N/A
Start date September 30, 2021
Completion date November 21, 2023

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