NCT01334268

RESOLUTE China RCT

A Randomized Controlled Trial of the Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in a Real-World All-comer Patient Population in China

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation.

Detailed description

This study is a prospective, multicenter, randomized, two-arm, open-label study, designed to assess the non-inferiority of Resolute stent compared to Taxus Liberte stent in in-stent late lumen loss. The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation. This trial will be conducted at approximately 20 sites and will enroll up to 400 subjects, randomized to the Resolute stent and Taxus Liberte stent in a 1:1 ratio. Subjects will be randomized using an interactive voice response system (IVRS). Due to the design characteristics of the devices, the study investigators and operators can not be blinded. However, the clinical event adjudication committee, consisting of cardiologists who are not participating in the study, will be blinded for the treatment arm of the subjects to avoid a potential bias in the adjudication process of events.

Conditions

• Ischemic Heart Disease
• Stenotic Coronary Lesion
• Cardiovascular Diseases
• Arteriosclerosis
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Taxus Liberte Paclitaxel-Eluting Coronary Stent System	Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation
DEVICE	Resolute Zotarolimus-Eluting Coronary Stent System	Resolute Zotarolimus-Eluting Coronary Stent System Implantation

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-11-01
• Completion: 2017-06-30
• First posted: 2011-04-13
• Last updated: 2017-10-18

Locations

4 sites across 1 country: China