NCT02133287

To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization

A Prospective, Multi-center, Randomized Trial To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Beijing AmsinoMed Medical Device Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating Coronary Revascularization.

Detailed description

The study is a Prospective, Open-lable, Multi-center, Randomized trial. 2000 primary coronary artery disease patients will be enrolled with a 1:1 randomization ratio(AVI:1000,Firebird 2:1000) at approximately 40 sites, Subject follow-up be at 30 days, 6 months, 9 months, 12 months, 2-5 years after procedure.

Conditions

• Ischemic Heart Disease
• Myocardial Ischemia
• Coronary Disease
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	AVI® Arsenic trioxide drug eluting stent delivery system
DEVICE	Firebird2® sirolimus eluting stent system

Timeline

• Start date: 2013-08-01
• Primary completion: 2018-06-01
• Completion: 2022-11-01
• First posted: 2014-05-08
• Last updated: 2019-11-15

Locations

1 site across 1 country: China