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

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)

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)

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Paclitaxel Coated PTCA Balloon Catheter

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Follow-up angiography at 6 months after procedure

Collaborators and Investigators

• Sponsor: Genoss Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: In-Stent Restenosis
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: CEP-DS1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No