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OpenTrials
Completed

NCT Number: NCT02520180

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Firehawk™ stent system

Device

MicroPort Firehawk™ biodegradable polymer rapamycin target eluting stent

Other names: MicroPort Firehawk™ rapamycin target eluting stent

Abbott Xience family Everolimus-Eluting Stent

Device

Abbott Xience family Everolimus-Eluting Stent

Primary outcomes

  1. Target Lesion Failure

    Time frame: 12 months

    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

Secondary outcomes

  1. In-stent late loss

    Time frame: 13 months

    In-stent late loss at 13 months post-procedure as measured by quantitative coronary angiography (QCA)

  2. stent struth Neointimal thickness

    Time frame: 3 months

    stent struth Neointimal thickness at 3 months measured by Optical Coherence Tomography (OCT)

Sponsors and collaborators

Lead sponsor

Shanghai MicroPort Medical (Group) Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2022
First posted
Aug 11, 2015
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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