Rigshospitalet
Copenhagen, Denmark
NCT Number: NCT02520180
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MicroPort Firehawk™ biodegradable polymer rapamycin target eluting stent
Other names: MicroPort Firehawk™ rapamycin target eluting stent
Abbott Xience family Everolimus-Eluting Stent
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
Time frame: 13 months
In-stent late loss at 13 months post-procedure as measured by quantitative coronary angiography (QCA)
Time frame: 3 months
stent struth Neointimal thickness at 3 months measured by Optical Coherence Tomography (OCT)
Shanghai MicroPort Medical (Group) Co., Ltd.
Industry
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)
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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