NCT05096442

Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions

A Multicenter, Prospective, Randomized, Single-blind, Pivotal Clinical Study to Evaluate the Safety and Efficacy of GENOSS® DCB Versus SeQuent® Please NEO in Patients With Coronary De Novo Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Genoss Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	GENOSS® DCB	Drug Coated Balloon
DEVICE	SeQuent® Please NEO	Drug Coated Balloon

Timeline

• Start date: 2021-09-30
• Primary completion: 2023-06-28
• Completion: 2023-11-21
• First posted: 2021-10-27
• Last updated: 2024-05-17

Locations

1 site across 1 country: South Korea