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

NCT ID: NCT02520180

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1653 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2022-06-30

Brief Summary

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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

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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

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Firehawk™ stent system

MicroPort Firehawk™ stent system

Group Type EXPERIMENTAL

Firehawk™ stent system

Intervention Type DEVICE

MicroPort Firehawk™ biodegradable polymer rapamycin target eluting stent

Xience family Everolimus-Eluting Stent

Abbott Xience family Everolimus-Eluting Stent

Group Type ACTIVE_COMPARATOR

Abbott Xience family Everolimus-Eluting Stent

Intervention Type DEVICE

Abbott Xience family Everolimus-Eluting Stent

Interventions

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Firehawk™ stent system

MicroPort Firehawk™ biodegradable polymer rapamycin target eluting stent

Intervention Type DEVICE

Abbott Xience family Everolimus-Eluting Stent

Abbott Xience family Everolimus-Eluting Stent

Intervention Type DEVICE

Other Intervention Names

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MicroPort Firehawk™ rapamycin target eluting stent

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai MicroPort Medical (Group) Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Wijns, MD, PhD

Role: STUDY_CHAIR

VZW Cardiovascular Research Center Aalst

Andreas Baumbach, MD

Role: PRINCIPAL_INVESTIGATOR

Bristol Heart Institute/University Hospitals Bristol NHS Foundation Trust,UK

Alexandra Lansky, MD

Role: PRINCIPAL_INVESTIGATOR

Yale Cardiovascular Research Group,USA

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 31129092 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30190206 (View on PubMed)

Other Identifiers

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TARGET AC

Identifier Type: -

Identifier Source: org_study_id

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