ProStent Coronary Drug-Eluting Stent

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00887211
Study type	Interventional
Source	CCRF Consulting Co., Ltd.
Contact	Xiaohong He
Phone	86-10-84094918
Email	danielle_he@ccheart.com.cn
Status	Recruiting
Phase	N/A
Start date	October 2008
Completion date	March 2010

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ProStent Coronary Drug-Eluting Stent — Prostent

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms