NCT04767022

Compare the Safety and Effectiveness of Genoss® DCB and SeQuent® Please NEO in Chinese Patients with Coronary ISR

A Prospective, Multicenter, Randomized Controlled Trials to Evaluate the Safety and Effectiveness of Genoss® DCB Versus SeQuent® Please NEO in Patients with Coronary In-stent Restenosis (ISR)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Genoss Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of Genoss® DCB by demonstrating non-inferiority in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please NEO). The experimental group was treated with Genoss® DCB, and the control group was treated with SeQuent® Please NEO. In this study, the end point of 9 months after procedure was used as the main endpoint to evaluate the effectiveness of Paclitaxel coated PTCA balloon catheter. The safety of the catheter was evaluated by cardiovascular adverse events.

Detailed description

In a randomized controlled trials to compare with the same-category medical device (Sequent® Please NEO), 224 patients with in-stent restenosis (ISR) were recruited from a total of 13 institutions, and the enrolled subjects were 1: 1 through randomization. The ratio was assigned to the test group(Genoss® DCB) and the control group(SeQuent® Please NEO), and each of the test or control devices was assigned to receive the procedure. All patients were followed up 30 days, 6 months, 9 months, 1 year and 2 years after procedure, and angiographic follow-up was performed 9 months after procedure.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB)	Drug Coated Balloon
DEVICE	Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)	Drug Coated Balloon

Timeline

• Start date: 2021-01-30
• Primary completion: 2023-12-20
• Completion: 2024-05-30
• First posted: 2021-02-23
• Last updated: 2025-02-21

Locations

1 site across 1 country: China