ProStent Coronary Drug-Eluting Stent (Prostent)
Recruitment status was Recruiting
A single blind, multi-center, randomized study is preformed to compare ProStent drug-eluting stents with Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of ProStent drug-eluting stent in treating coronary artery lesions.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Clinical Trial Program of a Medical Instrument Product|
- Late luminal loss(LLL) detected through quantity coronary angiography (QCA) at 270 days(±30days) follow-up [ Time Frame: 270 days(±30days) ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||March 2010|
|Estimated Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Active Comparator: ProStent
implant ProStent drug-eluting stents
ProStent rapamycin-eluting stent system manufactured by Tianjian Medical Technology (Suzhou) Co., Ltd.
Other Name: ProStent rapamycin-eluting stent system
Active Comparator: Firebird
implant Firebird drug-eluting stents
Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd.
Other Name: Firebird drug-eluting stents
A single blind, multi-center, randomized study is preformed to compare ProStent drug-eluting stents with Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of ProStent drug-eluting stent 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 and 365 days. 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.
|Contact: Xiaohong He||86-10-84094918 ext firstname.lastname@example.org|
|Beijing, China, 100037|
|Contact: Runlin Gao email@example.com|
|Principal Investigator:||Runlin Gao||Fuwai Hospital|