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Trial record 48 of 77 for:    "Heart Disease" | "Cobalt"

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

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ClinicalTrials.gov Identifier: NCT02520180
Recruitment Status : Recruiting
First Posted : August 11, 2015
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai MicroPort Medical (Group) Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Firehawk™ stent system Device: Abbott Xience family Everolimus-Eluting Stent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1656 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 2015
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Firehawk™ stent system
MicroPort Firehawk™ stent system
Device: Firehawk™ stent system
MicroPort Firehawk™ biodegradable polymer rapamycin target eluting stent
Other Name: MicroPort Firehawk™ rapamycin target eluting stent

Active Comparator: Xience family Everolimus-Eluting Stent
Abbott Xience family Everolimus-Eluting Stent
Device: Abbott Xience family Everolimus-Eluting Stent
Abbott Xience family Everolimus-Eluting Stent




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520180


Contacts
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Contact: Ming Zheng, MD mzheng@microport.com

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Lene Holmvang, MD       Lene.Holmvang@regionh.dk   
Principal Investigator: Lene Holmvang, MD         
Sponsors and Collaborators
Shanghai MicroPort Medical (Group) Co., Ltd.
Investigators
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Study Chair: William Wijns, MD, PhD VZW Cardiovascular Research Center Aalst
Principal Investigator: Andreas Baumbach, MD Bristol Heart Institute/University Hospitals Bristol NHS Foundation Trust,UK
Principal Investigator: Alexandra Lansky, MD Yale Cardiovascular Research Group,USA

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai MicroPort Medical (Group) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02520180     History of Changes
Other Study ID Numbers: TARGET AC
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Diseases
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents