Trials / Unknown
UnknownNCT01226355
NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System
Clinical Trial Program of a Medical Instrument Product
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Medfavour (Beijing) Medical Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.
Detailed description
A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. 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, 90, 180, 270,365 days,2 years,3 years,4 years and 5 years. Especially, standard quantity coronary angiography (QCA) will be conducted at 270 days (±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents. Major adverse cardiac events (MACEs) 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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | stent | NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System is manufactured by Medfavour (Beijing) Medical Co., Ltd. Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2010-12-01
- Completion
- 2014-11-01
- First posted
- 2010-10-22
- Last updated
- 2012-05-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01226355. Inclusion in this directory is not an endorsement.