NCT02216058

Safety and Efficacy Study of NOYA Sirolimus-Eluting Stent to Treat Coronary Artery Disease

A Prospective, Multicenter Trial of NOYA Sirolimus-Eluting Stent With Biodegradable Coating in Patients With Coronary Artery Disease

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

Summary

A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.

Detailed description

A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions. Appropriate patients judged by inclusion and exclusion standards will be preformed stent implantation, and after that all patients will be clinically followed up at 30, 180, 365 days,2 years,3 years,4 years and 5 years. Target Lesion Failure (TLF) found in following-up period as key indicators to evaluate the safety of stents. The arrangement, conclusion and statistical analysis of trial data including clinography and angiography will be fulfilled by independent Data Management Center(DMC) and radiography core laboratory.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System

Timeline

• Start date: 2013-04-01
• Primary completion: 2017-06-01
• Completion: 2020-06-01
• First posted: 2014-08-13
• Last updated: 2014-08-13

Locations

1 site across 1 country: China