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Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patient With Coronary In-stent Restenosis

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Paclitaxel Coated PTCA Balloon Catheter

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring In-Stent Restenosis

Eligibility Criteria

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

Inclusion Criteria:

Age ≥19 years old
Patients with significant coronary artery stenosis including left main coronary lesion (> 50% diameter stenosis on coronary angiography)
Patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic myocardial ischemia
Patients suitable to receive coronary revascularization of any type
Restenosis Mehran type I-III after stent implantation for the first time
Patients with In-stent restenosis after 90 days of the stent implantation, and the degree of restenosis corresponds to Mehran type I-Ⅲ.
Diameter of the stent with restenosis should be 2.0-4.0mm (included). Length of the stenosis lesion should be no more than 40mm
In case of voluntarily deciding to participate in this clinical trial by signing the informed consent form

Exclusion Criteria:

Patients with Infarct related artery (IRA) lesions among patients with acute myocardial infarction
Patients have restenosis lesions with thrombosis
Patients with a history of cardiogenic shock
Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis)
Patients with graft vessel lesion
Patients who are contraindicated in aspirin, heparin, clopidogrel, ticlopidine, and paclitaxel
Patients with renal insufficiency (eGFR<30mL/min)
Pregnant or lactating women
The patients have a life expectancy of less than 12 months
Patients who had reduced immunity or clinically significant abnormalities in the laboratory tests (hematological, serum biochemical, and urine tests) performed at the time of screening
Patients who had clinically significant disorders in cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system, or mental illness that significantly affects this study
Patients who are unsuitable for the study according to the investigator judges

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Genoss® DCB

SeQuent® Please

Arm Description

Paclitaxel Coated PTCA Balloon Catheter

Outcomes

Primary Outcome Measures

In-segment late lumen loss after percutaneous coronary intervention in patients with ISR

In-segment late lumen loss between test group(Genoss DCB) and control group(Sequent Please) evaluated by quantitiative coronary analysis in patients with ISR

Secondary Outcome Measures

Full Information

NCT ID

NCT04405063

First Posted

May 18, 2020

Last Updated

October 13, 2021

Sponsor

Genoss Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04405063

Brief Title

Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patient With Coronary In-stent Restenosis

Official Title

A Prospective, Multicenter, Sponsor Initiated, Randomized Controlled Trials to Evaluate the Safety and Efficacy of Genoss® DCB Compared to Sequent® Please in Korean Patients With Coronary Artery In-stent Restenosis (ISR)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

November 2016 (Actual)

Primary Completion Date

February 2019 (Actual)

Study Completion Date

February 2019 (Actual)

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 Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-segment late lumen loss at 6 months after the procedure in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please)

Detailed Description

In a randomized controlled trials to compare with the same-category medical device (Sequent® Please), 82 patients with in-stent restenosis (ISR) were recruited from a total of 7 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. Drug release "stents" for PCI usually follow 9 months or 12 months, but the medical device for this clinical trial has a drug coated "balloon catheter" and the mechanism of action is different from the stent and the duration of follow up was set to 6 months.

6. Conditions and Keywords

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

Coronary Artery Disease

Keywords

In-Stent Restenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Genoss® DCB

Arm Type

Experimental

Arm Description

Paclitaxel Coated PTCA Balloon Catheter

Arm Title

SeQuent® Please

Arm Type

Active Comparator

Arm Description

Paclitaxel Coated PTCA Balloon Catheter

Intervention Type

Device

Intervention Name(s)

Paclitaxel Coated PTCA Balloon Catheter

Intervention Description

Drug coated balloon

Primary Outcome Measure Information:

Title

In-segment late lumen loss after percutaneous coronary intervention in patients with ISR

Description

In-segment late lumen loss between test group(Genoss DCB) and control group(Sequent Please) evaluated by quantitiative coronary analysis in patients with ISR

Time Frame

Follow-up angiography at 6 months after procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥19 years old Patients with significant coronary artery stenosis including left main coronary lesion (> 50% diameter stenosis on coronary angiography) Patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic myocardial ischemia Patients suitable to receive coronary revascularization of any type Restenosis Mehran type I-III after stent implantation for the first time Patients with In-stent restenosis after 90 days of the stent implantation, and the degree of restenosis corresponds to Mehran type I-Ⅲ. Diameter of the stent with restenosis should be 2.0-4.0mm (included). Length of the stenosis lesion should be no more than 40mm In case of voluntarily deciding to participate in this clinical trial by signing the informed consent form Exclusion Criteria: Patients with Infarct related artery (IRA) lesions among patients with acute myocardial infarction Patients have restenosis lesions with thrombosis Patients with a history of cardiogenic shock Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis) Patients with graft vessel lesion Patients who are contraindicated in aspirin, heparin, clopidogrel, ticlopidine, and paclitaxel Patients with renal insufficiency (eGFR<30mL/min) Pregnant or lactating women The patients have a life expectancy of less than 12 months Patients who had reduced immunity or clinically significant abnormalities in the laboratory tests (hematological, serum biochemical, and urine tests) performed at the time of screening Patients who had clinically significant disorders in cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system, or mental illness that significantly affects this study Patients who are unsuitable for the study according to the investigator judges

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36339121

Citation

Jun EJ, Shin ES, Yuan SL, Bhak Y, Garg S, Kang WC, Kim JS, Kim JH, Bae JW, Rha SW, Chae IH. Comparison of 2 Different Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis: A Randomized Controlled Trial. JACC Asia. 2022 Mar 1;2(2):170-179. doi: 10.1016/j.jacasi.2021.11.015. eCollection 2022 Apr.

Results Reference

derived

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Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patient With Coronary In-stent Restenosis

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