NCT02844270

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Shanghai Bio-heart Biological Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Diseases

Interventions

Type	Name	Description
DEVICE	Rapamycin Drug-Eluting Bioresorbable Coronary Stent System	Implantation of the Rapamycin Drug-Eluting Bioresorbable Coronary Stent System

Timeline

• Start date: 2016-08-09
• Primary completion: 2016-12-22
• Completion: 2021-12-01
• First posted: 2016-07-26
• Last updated: 2019-11-21