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Galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System First-in-man Study

Heart Diseases Clinical Trial

Official title:
The Feasibility, Safety and Efficacy Evaluation of Galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System for the Treatment of Coronary Heart Disease: a First-in-man Study

Clinical Trial Summary

The Galaxy First-in-man study is a small pilot. single arm research , which will enroll a total of 45 patients. The goal is to access the feasibility, safety and efficacy of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in the treatment of patients with de novo coronary lesion.

Clinical Trial Description

This study is a prospective, single arm clinical trial. 45 patients enrolled in the study will be randomly assigned to queue1 (n=30) and queue 2 (n=15). The clinical follow-up will be performed in all subjects at 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after stent implantation; angiographic,IVUS and OCT follow-up will be performed at 6 months and 2 years after stent implantation in queue 1; angiographic,IVUS and OCT follow-up will be performed at 1 year and 3 years after stent implantation in queue 2. The primary endpoint of the study is target lesion failure (TLF) at 30 days after stent implantation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02844270
Study type Interventional
Source Shanghai Bio-heart Biological Technology Co., Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date August 9, 2016
Completion date December 2021
View Details
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