Trials / Unknown

UnknownNCT00887211

ProStent Coronary Drug-Eluting Stent

Clinical Trial Program of a Medical Instrument Product

Status: Unknown
Phase: N/A
Study type: Interventional
Enrollment: 290 (estimated)

Sponsor: CCRF Consulting Co., Ltd. · Academic / Other
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

Summary

Detailed 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.

Conditions

Coronary Disease

Interventions

Type	Name	Description
DEVICE	stent	ProStent rapamycin-eluting stent system manufactured by Tianjian Medical Technology (Suzhou) Co., Ltd.
DEVICE	stent	Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd.

Timeline

Start date: 2008-10-01
Primary completion: 2010-02-01
Completion: 2010-03-01
First posted: 2009-04-23
Last updated: 2009-04-30

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT00887211. Inclusion in this directory is not an endorsement.