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

NCT05096442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2024-05-17

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

GENOSS® DCB

Drug Coated Balloon

DEVICE

SeQuent® Please NEO

Drug Coated Balloon

Sponsors & Collaborators

  • Genoss Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Eun-Seok Shin, MD, PhD · Division of Cardiology, Ulsan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-06-28
Completion
2023-11-21

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT05096442 on ClinicalTrials.gov