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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Firehawk™ stent system; Device: Abbott Xience family Everolimus-Eluting Stent

• Registration Number: NCT02520180
• Lead Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-08-06
• Study First Posted: 2015-08-11
• Study Start: 2015-12
• Primary Completion: 2016-10
• Study Completion: 2022-06
• Status Verified: 2022-12
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1653

Inclusion Criteria

• Minimal age 18 years
• Symptomatic coronary artery disease
• Patient acceptable candidate for treatment with drug eluting stent in accordance with applicable guidelines
• Presence of one or more coronary artery stenosis >50% with reference diameter 2.25-4.0mm which can be covered by one or multiple stents
• Patient indication, lesion length and vessel diameter according to 'Instructions for Use' of study stents
• Patient is willing and able to cooperate with study procedures and required follow up visits and patient or legal representative has been informed and agrees by signing EC approved written informed consent

Exclusion Criteria

• Women of childbearing potential who do not have a negative pregnancy test within 7 days before procedure and women who are lactating
• Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel, chromium, molybdenum, polymer coatings, Sirolimus, Everolimus, or contrast material
• Participating in other trial before reaching primary endpoint
• Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Firehawk™ stent system	Firehawk™ stent system	MicroPort Firehawk™ stent system
Xience family Everolimus-Eluting Stent	Abbott Xience family Everolimus-Eluting Stent	Abbott Xience family Everolimus-Eluting Stent

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure	12 months	Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year

Secondary Outcome Measures

Name	Time	Method
In-stent late loss	13 months	In-stent late loss at 13 months post-procedure as measured by quantitative coronary angiography (QCA)
stent struth Neointimal thickness	3 months	stent struth Neointimal thickness at 3 months measured by Optical Coherence Tomography (OCT)

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark