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

MicroPort

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: Abbott Xience family Everolimus-Eluting Stent

Device: Firehawk™ stent system

Study type

Interventional

Funder types

Industry

Identifiers

NCT02520180

TARGET AC

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,653 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.