MedTrace Logo

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

NCT07159087 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-09-08

No results posted yet for this study

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.

Conditions

  • Coronary Arterial Disease (CAD)

Interventions

DEVICE

Sirolimus Coated PTCA Balloon Catheter(Genoss® SCB)

Drug Coated Balloon

DEVICE

Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)

Drug Coated Balloon

Sponsors & Collaborators

  • Synex Consulting Ltd

    collaborator UNKNOWN

  • Genoss Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • In-ho Chea, MD · Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-19
Primary Completion
2026-07-31
Completion
2027-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07159087 on ClinicalTrials.gov