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

Coronary Artery Disease Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04240444
Study type Interventional
Source B. Braun Medical International Trading Company Ltd.
Contact
Status Completed
Phase N/A
Start date October 10, 2020
Completion date August 30, 2022
View Details
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