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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Firehawk™ stent system
Abbott Xience family Everolimus-Eluting Stent
Sponsored by
Shanghai MicroPort Medical (Group) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Firehawk™ stent system

Xience family Everolimus-Eluting Stent

Arm Description

MicroPort Firehawk™ stent system

Abbott Xience family Everolimus-Eluting Stent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

In-stent late loss
In-stent late loss at 13 months post-procedure as measured by quantitative coronary angiography (QCA)
stent struth Neointimal thickness
stent struth Neointimal thickness at 3 months measured by Optical Coherence Tomography (OCT)

Full Information

First Posted
July 29, 2015
Last Updated
October 18, 2023
Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02520180
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
June 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1653 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Firehawk™ stent system
Arm Type
Experimental
Arm Description
MicroPort Firehawk™ stent system
Arm Title
Xience family Everolimus-Eluting Stent
Arm Type
Active Comparator
Arm Description
Abbott Xience family Everolimus-Eluting Stent
Intervention Type
Device
Intervention Name(s)
Firehawk™ stent system
Other Intervention Name(s)
MicroPort Firehawk™ rapamycin target eluting stent
Intervention Description
MicroPort Firehawk™ biodegradable polymer rapamycin target eluting stent
Intervention Type
Device
Intervention Name(s)
Abbott Xience family Everolimus-Eluting Stent
Intervention Description
Abbott Xience family Everolimus-Eluting Stent
Primary Outcome Measure Information:
Title
Target Lesion Failure
Description
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
12 months
Secondary Outcome Measure Information:
Title
In-stent late loss
Description
In-stent late loss at 13 months post-procedure as measured by quantitative coronary angiography (QCA)
Time Frame
13 months
Title
stent struth Neointimal thickness
Description
stent struth Neointimal thickness at 3 months measured by Optical Coherence Tomography (OCT)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Wijns, MD, PhD
Organizational Affiliation
VZW Cardiovascular Research Center Aalst
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andreas Baumbach, MD
Organizational Affiliation
Bristol Heart Institute/University Hospitals Bristol NHS Foundation Trust,UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexandra Lansky, MD
Organizational Affiliation
Yale Cardiovascular Research Group,USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31129092
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.
Results Reference
derived
PubMed Identifier
30190206
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.
Results Reference
derived

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

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