NCT01196819

Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial

A Prospective Multi-center Randomized Trial Assessing the Safety and Effectiveness of Biodegradable Polymer Target Release Rapamycin-Eluting STent vs. XIENCE V Everolimus-Eluting Stent for the Treatment of Coronary Artery Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 458 (actual)
• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.

Detailed description

The primary endpoint is in-stent late lumen loss after 9 months of the stent implantation. The secondary endpoint is in-stent percent diameter stenosis.This study is based on non-inferior assumption (vs. Xience V), requiring both endpoints reach statistical significance. Prespecified OCT follow-up is planned at 3-Year after index procedure at 3 chosen hospitals.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Firehawk	Implantation of Firehawk drug eluting stent
DEVICE	Xience V	Implantation of Xience V drug eluting stent

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-05-01
• Completion: 2016-12-01
• First posted: 2010-09-08
• Last updated: 2019-07-30
• Results posted: 2018-02-22

Locations

1 site across 1 country: China