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Coronary Bifurcation Lesions Treated With Biguard Stent System — BIGUARD  

Coronary Artery Disease Clinical Trial

Official title:
A Prospective, Multi-center, Randomized Trial Comparing Biguard Stent With Regular Sirolimus-eluting Stent System for Patients With Coronary Bifurcation Lesions

Clinical Trial Summary

This study is designed to test the hypothesis that the Biguard stent system will lead to fewer target lesion failure compared to regular stent system in patients with coronary bifurcation lesions at one year.

Clinical Trial Description

The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of Biguard bifurcation stent system and regular stent system in patients with bifurcation lesions. Based on the previous studies, the rate of 1-year target lesion failure was around 12% after PCI with regular stent system. And the investigators previous data showed that this event at 12-month after Biguard bifurcation stent system was 4%. Considering the lost to follow-up, it is anticipated that up to 400 patients will be enrolled in the trial. All patients will have repeat angiography at 13 months, with clinical follow-up to 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02597283
Study type Interventional
Source Nanjing First Hospital, Nanjing Medical University
Contact
Status Withdrawn
Phase N/A
Start date December 2015
Completion date December 2015
View Details
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