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

January 3, 2024 updated by: Genoss Co., Ltd.

A Multicenter, Prospective, Randomized, Single-blind, Pivotal Clinical Study to Evaluate the Safety and Efficacy of GENOSS® DCB Versus SeQuent® Please NEO in Patients With Coronary De Novo Lesions

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).

Study Overview

Status

Completed

Detailed Description

In a randomized controlled trial to compare with the same-category drug device (SeQuent® Please NEO), 204 patients with coronary de novo lesions were recruited from a total of 12 institutions, and the enrolled subjects were 1: 1 through randomization.

The ratio was assigned to the test group and the control group, and each of the test or control devices was assigned to receive the procedure.

The primary end point is the in-lesion late lumen loss of the target lesion at 6 months after the procedure, and the secondary end point is the target vessel failure (Composite of cardiac death, TV-MI, and ID-TVR) at 6 and 12 months after the procedure.

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥19 years old
  • Patients requiring PCI with coronary de novo lesions
  • Patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic myocardial ischemia
  • Women of childbearing age who agreed to use one or more of the clinically appropriate methods of contraception during the trial period.
  • In case of voluntarily deciding to participate in this clinical trial by signing the informed consent form

Inclusion criteria for coronary angiography

  • Patients with significant coronary artery stenosis (> 50% diameter stenosis on coronary angiography)
  • On coronary angiography, the length of the lesion is less than 34 mm and the diameter of the reference vessel of the coronary artery is 2.0 - 4.0mm.

Exclusion Criteria:

  • Patients with ST-segment elevation myocardial infarction (STEMI)
  • Patients who are contraindicated in aspirin, heparin, ticagrelor, iopromide, clopidogrel, prasugrel and paclitaxel
  • Patients with platelet aggregation or disorders at risk of increased bleeding, such as gastrointestinal ulcers, which limit platelet aggregation inhibitory therapy and anticoagulant therapy
  • Patients with a left ventricular ejection fraction of less than 30% on echocardiography
  • Patients with renal insufficiency (eGFR<30mL/min)
  • Patients with a history of cardiogenic shock
  • Pregnant or lactating women
  • The patients have a life expectancy of less than 12 months
  • Patients who have or currently have medical conditions such as psychiatric disorders that significantly affect this clinical trial
  • Patients who, in the investigator's judgment, may not be suitable for this clinical trial or may increase the risk associated with participation in the study
  • Patients who are currently participating in other clinical trials or have experience participating in other clinical trials within 90 days from the screening date
  • Patients who are unsuitable for the study according to the investigator judges

Exclusion criteria for coronary angiography

  • Patients with left main coronary lesion
  • Patients with graft vessel lesion
  • Patients who cannot apply pre-dilation or fail in pre-dilation to apply medical devices for clinical trials
  • Patients with one of the following items after pre-dilation of the target lesion

    • When FFR (Functional measurement) is measured as ≤ 0.8 in large vessels with a reference vessel diameter exceeding 2.75mm (However, depending on the judgment of the investigator, FFR measurement may not be performed.)
    • Patients who need stenting due to vascular dissection that restricts blood flow
    • Residual stenosis > 30%
    • TIMI flow < 3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Genoss® DCB
Paclitaxel Coated PTCA Balloon Catheter
Drug Coated Balloon
Other Names:
  • Paclitaxel Coated PTCA Balloon catheter
Active Comparator: SeQuent® Please NEO
Paclitaxel Coated PTCA Balloon Catheter
Drug Coated Balloon
Other Names:
  • Paclitaxel Coated PTCA Balloon catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-lesion late lumen loss after percutaneous coronary intervention in patients with coronary de novo lesions
Time Frame: Follow-up angiography at 6 months after the procedure
late lumen loss between test group and control group evaluated by quantitative coronary analysis in patients with coronary de novo lesions
Follow-up angiography at 6 months after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restenosis rate after percutaneous coronary intervention in patients with coronary de novo lesions
Time Frame: Follow-up angiography at 6 months after procedure
Restenosis is defined as a case where the DS(Diameter stenosis) of the reference vessel diameter is 50% or more when the successfully treated lesion is evaluated through coronary angiography.
Follow-up angiography at 6 months after procedure
Target vessel failure(TVF)
Time Frame: at 6 and 12 months after the procedure
Composite of TVF(cardiac death, TV-MI, and ID-TVR)
at 6 and 12 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eun-Seok Shin, MD, PhD, Division of Cardiology, Ulsan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2021

Primary Completion (Actual)

June 28, 2023

Study Completion (Actual)

November 21, 2023

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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