Non-inferiority Study Comparing Firehawk Stent With Abbott Xience Family Stent (TARGET-AC)
NCT ID: NCT02520180
Last Updated: 2023-10-23
Study Results
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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COMPLETED
NA
1653 participants
INTERVENTIONAL
2015-12-31
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Firehawk™ stent system
MicroPort Firehawk™ stent system
Firehawk™ stent system
MicroPort Firehawk™ biodegradable polymer rapamycin target eluting stent
Xience family Everolimus-Eluting Stent
Abbott Xience family Everolimus-Eluting Stent
Abbott Xience family Everolimus-Eluting Stent
Abbott Xience family Everolimus-Eluting Stent
Interventions
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Firehawk™ stent system
MicroPort Firehawk™ biodegradable polymer rapamycin target eluting stent
Abbott Xience family Everolimus-Eluting Stent
Abbott Xience family Everolimus-Eluting Stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Shanghai MicroPort Medical (Group) Co., Ltd.
INDUSTRY
Responsible Party
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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
Countries
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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.
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.
Other Identifiers
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TARGET AC
Identifier Type: -
Identifier Source: org_study_id
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