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

Conditions

Coronary Artery Disease

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.

Patel KP, Lansky AJ, Kelbæk H, Xu B, van Royen N, Johnson TW, Anderson R, Wijns W, Baumbach A, TARGET AC investigators.

2024-02-112 citations

10.1016/j.amjcard.2023.12.002

Validation of the all-comers design: Results of the TARGET-AC substudy.

G Toth G, Lansky A, Baumbach A, Kelbæk H, van Royen N, Holmvang L, Janssens L, Brugaletta S, Barbato E, Maillard L, Kiemeneij F, Naber CK, Pucher F, Laursen PN, Ameloot K, Robles C, Milkas A, Sevilla J, Jensen C, Wijns W.

2019-11-271 citations

10.1016/j.ahj.2019.10.019

Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial.

Lansky A, Wijns W, Xu B, Kelbæk H, van Royen N, Zheng M, Morel MA, Knaapen P, Slagboom T, Johnson TW, Vlachojannis G, Arkenbout KE, Holmvang L, Janssens L, Ochala A, Brugaletta S, Naber CK, Anderson R, Rittger H, Berti S, Barbato E, Toth GG, Maillard L, Valina C, Buszman P, Thiele H, Schächinger V, Baumbach A, TARGET All Comers Investigators.

2018-09-0346 citations

10.1016/s0140-6736(18)31649-0

Interventions

DEVICEFirehawk™ stent system

MicroPort Firehawk™ biodegradable polymer rapamycin target eluting stent

DEVICEAbbott Xience family Everolimus-Eluting Stent

Abbott Xience family Everolimus-Eluting Stent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Denmark

Outcome results

None listed