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Compare the Safety and Effectiveness of Genoss® DCB and SeQuent® Please NEO in Chinese Patients with Coronary ISR

NCT04767022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2025-02-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of Genoss® DCB by demonstrating non-inferiority in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please NEO).

The experimental group was treated with Genoss® DCB, and the control group was treated with SeQuent® Please NEO.

In this study, the end point of 9 months after procedure was used as the main endpoint to evaluate the effectiveness of Paclitaxel coated PTCA balloon catheter. The safety of the catheter was evaluated by cardiovascular adverse events.

Conditions

Interventions

DEVICE

Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB)

Drug Coated Balloon

DEVICE

Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)

Drug Coated Balloon

Sponsors & Collaborators

  • Genoss Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ling Tao · Department of Cardiology, First Affiliated Hospital of Air Force Medical University of Chinese PLA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-30
Primary Completion
2023-12-20
Completion
2024-05-30

Countries

  • China

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 NCT04767022 on ClinicalTrials.gov