NCT04405063

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Genoss Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Paclitaxel Coated PTCA Balloon Catheter	Drug coated balloon

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2020-05-28
• Last updated: 2024-05-17