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ENROLLING BY INVITATION
NCT07159087
NA

The Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss® SCB' Versus 'SeQuent® Please NEO' in Patients With Coronary ISR

Sponsor: Genoss Co., Ltd.

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate the safety and effectiveness of Genoss® SCB by comparing in-segment late lumen loss (LLL) to the control group (SeQuent® Please NEO) at 6 months in patients with coronary stent-in-stent restenosis (ISR) with a reference vessel diameter of 2.0-4.0 mm.

Official title: A Multicenter, Prospective, Randomized, Double-blind, Pivotal Clinical Trial to Compare the Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss® SCB' Versus 'SeQuent® Please NEO' in Patients With Coronary ISR

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2025-02-19

Completion Date

2027-01-31

Last Updated

2025-09-08

Healthy Volunteers

No

Interventions

DEVICE

Sirolimus Coated PTCA Balloon Catheter(Genoss® SCB)

Drug Coated Balloon

DEVICE

Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)

Drug Coated Balloon

Locations (1)

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea