Clinical trial NCT02520180: Non-inferiority Study Comparing Firehawk Stent With Abbott Xience Family Stent (TARGET-AC)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-08-11
Enrollment: 1653
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Target Lesion Failure
timeFrame: 12 months
Secondary outcomes:
measure: In-stent late loss
timeFrame: 13 months
measure: stent struth Neointimal thickness
timeFrame: 3 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: VZW Cardiovascular Research Center Aalst
name: William Wijns, MD, PhD
role: STUDY_CHAIR
affiliation: Bristol Heart Institute/University Hospitals Bristol NHS Foundation Trust,UK
name: Andreas Baumbach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale Cardiovascular Research Group,USA
name: Alexandra Lansky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.