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)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Firehawk™ stent system; Device: Abbott Xience family Everolimus-Eluting Stent

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 Type: Interventional
• Enrollment (Actual): 1653
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Firehawk™ stent system; MicroPort Firehawk™ stent system	Device: Firehawk™ stent system; MicroPort Firehawk™ biodegradable polymer rapamycin target eluting stent; Other Names: MicroPort Firehawk™ rapamycin target eluting stent
Active Comparator: Xience family Everolimus-Eluting Stent; Abbott Xience family Everolimus-Eluting Stent	Device: Abbott Xience family Everolimus-Eluting Stent; Abbott Xience family Everolimus-Eluting Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure	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	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
• Investigators: Study Chair: William Wijns, MD, PhD, VZW Cardiovascular Research Center Aalst; Principal Investigator: Andreas Baumbach, MD, Bristol Heart Institute/University Hospitals Bristol NHS Foundation Trust,UK; Principal Investigator: Alexandra Lansky, MD, Yale Cardiovascular Research Group,USA

Publications and helpful links

General Publications

• Xu B, Saito Y, Baumbach A, Kelbaek 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, Schachinger V, Lansky A, Wijns W; TARGET AC Investigators. 2-Year Clinical Outcomes of an Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1679-1687. doi: 10.1016/j.jcin.2019.05.001. Epub 2019 May 22.
• Lansky A, Wijns W, Xu B, Kelbaek 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, Schachinger V, Baumbach A; TARGET All Comers Investigators. 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. Lancet. 2018 Sep 29;392(10153):1117-1126. doi: 10.1016/S0140-6736(18)31649-0. Epub 2018 Sep 3.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: July 29, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimated): August 11, 2015

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protein Kinase Inhibitors; MTOR Inhibitors; Everolimus
• Other Study ID Numbers: TARGET AC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO