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

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04405063
• Other study ID #: CEP-DS1001
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: February 2019

Study information

• Verified date: October 2021
• Source: Genoss Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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-?.

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Paclitaxel Coated PTCA Balloon Catheter
Drug coated balloon

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genoss Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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