NCT02520180

Non-inferiority Study Comparing Firehawk Stent With Abbott Xience Family Stent (TARGET-AC)

A Prospective Multicenter Post Market Trial to Assess the Safety and Effectiveness of the Firehawk™ Rapamycin Target Eluting Cobalt Chromium Coronary Stent System (Firehawk™ Stent System) for the Treatment of Atherosclerotic Lesion(s)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,653 (actual)
• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Purpose The TARGET All comers trial is a prospective, multicenter, randomized, two-arm, non-inferiority, open-label study with 1656 patients at 20 centers in Europe. The study is a "real world, all comers" study.

Detailed description

Primary objective: to compare the MicroPort Medical (Group) Co., Ltd Firehawk™cobalt chromium coronary stent ( rapamycin target eluting ) system with abluminal grooves containing a biodegradable polymer with the Abbott XIENCE family EES (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a "real world" patient population.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Firehawk™ stent system	MicroPort Firehawk™ biodegradable polymer rapamycin target eluting stent
DEVICE	Abbott Xience family Everolimus-Eluting Stent	Abbott Xience family Everolimus-Eluting Stent

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-10-01
• Completion: 2022-06-01
• First posted: 2015-08-11
• Last updated: 2023-10-23

Locations

1 site across 1 country: Denmark