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

Genoss

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: Paclitaxel Coated PTCA Balloon Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT04405063

CEP-DS1001

Details and patient eligibility

About

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)

Full 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.

Enrollment

82 patients

Sex

All

Ages

19+ years old

Volunteers

No 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