NCT04240444

Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Assess the Safety and Efficacy of SeQuent® SCB Balloon in the Treatment of Patients With Coronary Arteries In-stent Restenosis Compared SeQuent® Please Neo

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: B. Braun Medical International Trading Company Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized controlled clinical trial, which plans to enroll 260 subjects.

Detailed description

This is a prospective, multicenter, randomized (1:1) controlled clinical trial, which plans to enroll 260 subjects. The aim of study is to assess the safety and efficacy of SeQuent® SCB in the treatment of in-stent restenosis in coronary arteries. All eligible subjects with ISR lesion in coronary will be randomly assigned to receive SeQuent® SCB (study group) or receive SeQuent® Please Neo (control group) balloon treatment. All subjects will be scheduled to clinical follow up at 30 days, 6 months, 9 months and 12 months after index procedure and will be scheduled to receive the angiography at 9 months after index procedure. The primary endpoint was segment late luminal loss at 9 months after index procedure.

Conditions

• Coronary Artery Disease
• In Stent Restenosis

Interventions

Type	Name	Description
DEVICE	drug-coated balloon Catheter	All eligible subjects will be assigned randomly to study group or control group, receive PTCA.

Timeline

• Start date: 2020-10-10
• Primary completion: 2022-07-26
• Completion: 2022-08-30
• First posted: 2020-01-27
• Last updated: 2023-11-14

Locations

16 sites across 1 country: China