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

Sponsor

Genoss Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04405063

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: Paclitaxel Coated PTCA Balloon Catheter	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Genoss® DCB Paclitaxel Coated PTCA Balloon Catheter	Device: Paclitaxel Coated PTCA Balloon Catheter Drug coated balloon
Active Comparator: SeQuent® Please Paclitaxel Coated PTCA Balloon Catheter	Device: Paclitaxel Coated PTCA Balloon Catheter Drug coated balloon

Arm

Intervention/Treatment

Experimental: Genoss® DCB

Paclitaxel Coated PTCA Balloon Catheter

Device: Paclitaxel Coated PTCA Balloon Catheter

Drug coated balloon

Active Comparator: SeQuent® Please

Paclitaxel Coated PTCA Balloon Catheter

Device: Paclitaxel Coated PTCA Balloon Catheter

Drug coated balloon

Outcome Measures

Primary Outcome Measures

In-segment late lumen loss after percutaneous coronary intervention in patients with ISR [Follow-up angiography at 6 months after procedure]
In-segment late lumen loss between test group(Genoss DCB) and control group(Sequent Please) evaluated by quantitiative coronary analysis in patients with ISR

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Genoss Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genoss Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04405063

Other Study ID Numbers:

CEP-DS1001

First Posted:

May 28, 2020

Last Update Posted:

Oct 21, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Genoss Co., Ltd.

In-Stent Restenosis

Additional relevant MeSH terms:

Coronary Artery Disease

Paclitaxel

Study Results

No Results Posted as of Oct 21, 2021