NCT04386213

Trial for MicroPort's DCB

A Prospective, Multicenter, Randomized Trial in Evaluating the Safety and Efficacy of the Paclitaxel Drug-coated Coronary Artery Balloon Catheter in Patients With Coronary Artery In-stent Restenosis Compared to SeQuent® Please Paclitaxel Drug-coated Coronary Artery Balloon Catheter

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, controlled clinical research and aims to evaluate the safety and efficacy of the paclitaxel drug-coated coronary artery balloon catheter in patients with coronary artery in-stent restenosis compared to seQuent® please paclitaxel drug-coated coronary artery balloon catheter.

Detailed description

This prospective, multicenter, randomized controlled clinical study is designed to enroll 216 subjects with in-stent restenosis and randomly assign them to the trial and control groups on a 1:1 basis.The experimental group was treated with paclitaxel drug-coated coronary artery balloon catheter, and the control group was treated with SeQuent ® Please paclitaxel balloon catheter, which has been marketed. In-segment late lumen loss 9 months after surgery was the main end point of the study. All subjects were followed up clinically at 1 month, 6 months, 9 months, 1 year and 2 years after the surgery, and were followed up with angiography at 9 months after the surgery.

Conditions

• Coronary Artery In-stent Restenosis

Interventions

Type	Name	Description
DEVICE	coronary artery in-stent restenosis	treat the petients with coronary artery in-stent restenosis

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-12-01
• Completion: 2025-07-31
• First posted: 2020-05-13
• Last updated: 2020-05-13