NCT02284750

Two-stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions

A Prospective, Multi-center, Randomized Trial Comparing Two-stent With Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 660 (actual)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish the optimal strategy for stenting in coronary bifurcation lesion.

Detailed description

The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of two-stenting and simple stenting techniques in patients with complex bifurcation lesions. Based on the previous studies, the rate of 1-year target lesion failure events was around 14% after PCI with provisional stenting. And our previous data showed that this event at 12-month after two-stenting procedure was 7%. Considering the lost to follow-up, it is anticipated that up to 660 patients will be enrolled in the trial. All patients will have repeat angiography at 13 months, with clinical follow-up to 5 years.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Percutaneous coronary intervention

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2014-11-06
• Last updated: 2019-12-16

Locations

1 site across 1 country: China