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

Primary Purpose

Coronary Artery Disease

Status

Active

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GENOSS® DCB

SeQuent® Please NEO

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring de novo lesions

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 including left main coronary lesion (> 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 ≤ 0.8 in large vessels with a diameter of 3.0 mm or more (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

Sites / Locations

Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Genoss® DCB

SeQuent® Please NEO

Arm Description

Paclitaxel Coated PTCA Balloon Catheter

Outcomes

Primary Outcome Measures

in-lesion late lumen loss after percutaneous coronary intervention in patients with coronary de novo lesions

late lumen loss between test group and control group evaluated by quantitative coronary analysis in patients with coronary de novo lesions

Secondary Outcome Measures

Restenosis rate after percutaneous coronary intervention in patients with coronary de novo lesions

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.

Target vessel failure(TVF)

Composite of TVF(cardiac death, TV-MI, and ID-TVR)

Full Information

NCT ID

NCT05096442

First Posted

October 14, 2021

Last Updated

September 11, 2023

Sponsor

Genoss Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05096442

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 15, 2021 (Actual)

Primary Completion Date

June 30, 2023 (Actual)

Study Completion Date

December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genoss Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

de novo lesions

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

204 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Genoss® DCB

Arm Type

Experimental

Arm Description

Paclitaxel Coated PTCA Balloon Catheter

Arm Title

SeQuent® Please NEO

Arm Type

Active Comparator

Arm Description

Paclitaxel Coated PTCA Balloon Catheter

Intervention Type

Device

Intervention Name(s)

GENOSS® DCB

Other Intervention Name(s)

Paclitaxel Coated PTCA Balloon catheter

Intervention Description

Drug Coated Balloon

Intervention Type

Device

Intervention Name(s)

SeQuent® Please NEO

Other Intervention Name(s)

Paclitaxel Coated PTCA Balloon catheter

Intervention Description

Drug Coated Balloon

Primary Outcome Measure Information:

Title

in-lesion late lumen loss after percutaneous coronary intervention in patients with coronary de novo lesions

Description

late lumen loss between test group and control group evaluated by quantitative coronary analysis in patients with coronary de novo lesions

Time Frame

Follow-up angiography at 6 months after the procedure

Secondary Outcome Measure Information:

Title

Restenosis rate after percutaneous coronary intervention in patients with coronary de novo lesions

Description

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.

Time Frame

Follow-up angiography at 6 months after procedure

Title

Target vessel failure(TVF)

Description

Composite of TVF(cardiac death, TV-MI, and ID-TVR)

Time Frame

at 6 and 12 months after the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 including left main coronary lesion (> 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 ≤ 0.8 in large vessels with a diameter of 3.0 mm or more (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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eun-Seok Shin, MD, PhD

Organizational Affiliation

Division of Cardiology, Ulsan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ulsan University Hospital

City

Ulsan

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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