NCT01412164

Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)

A Prospective Multicenter Single-Arm Observational Registry Study Assessing the Safety and Efficacy of FIREHAWK Biodegradable Polymer Target-release Rapamycin-eluting Stent for the Treatment of Coronary Artery Disease: TARGET II

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 730 (actual)
• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study aims to further assess the safety, efficacy and the performance of its delivery system of FIREHAWK rapamycin-eluting stent up to five years.

Detailed description

This is a prospective open-labeled, multi-center, single-arm observational registry study. Approximately 1,100 subjects will be enrolled to evaluate the TLF as the primary endpoint at 12-month. Also, the study will follow up those subjects up to 5 years as the secondary endpoints.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	FIREHAWK biodegradable polymer rapamycin-eluting stent	DES PCI for CAD

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-02-01
• Completion: 2017-01-01
• First posted: 2011-08-09
• Last updated: 2019-08-26
• Results posted: 2016-03-17

Locations

1 site across 1 country: China