NCT02117843

The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization

A Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Beijing AmsinoMed Medical Device Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization.

Detailed description

The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization, 1200 primary coronary artery disease patients will be enrolled, at approximately 40 sites. Subject follow-up will occur via telephone contact or clinical visit 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	AVI® Arsenic trioxide drug eluting stent

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-12-01
• Completion: 2021-04-01
• First posted: 2014-04-21
• Last updated: 2017-06-27

Locations

1 site across 1 country: China