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

Study Overview
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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.

Official Title
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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)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Firehawk™ stent system
* Device: Abbott Xience family Everolimus-Eluting Stent


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |