NCT07159087

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Genoss Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This pivotal study is a randomized controlled trial to compare with the control group (SeQuent® Please NEO), and will recruit 94 patients with in-stent restenosis (ISR) from 9 institutions. The test group (Genoss® SCB) and the control group (SeQuent® Please NEO) will be randomly assigned 1:1, and all patients will be followed up at 1, 6, and 12 months after the procedure. The primary endpoint is to evaluate in-segment late lumen loss by quantitative coronary angiography (QCA) by an independent assessor at 6 months after the procedure.

Conditions

• Coronary Arterial Disease (CAD)

Interventions

Type	Name	Description
DEVICE	Sirolimus Coated PTCA Balloon Catheter(Genoss® SCB)	Drug Coated Balloon
DEVICE	Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)	Drug Coated Balloon

Timeline

• Start date: 2025-02-19
• Primary completion: 2026-07-31
• Completion: 2027-01-31
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

1 site across 1 country: South Korea