NCT02597283

Coronary Bifurcation Lesions Treated With Biguard Stent System

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Biguard sirolimus-eluting bifurcation stent system	PCI with Biguard sirolimus-eluting bifurcation stent system
DEVICE	Sirolimus-eluting stent system	PCI with sirolimus-eluting stent system

Timeline

• Start date: 2015-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-11-05
• Last updated: 2017-12-06