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

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520180
• Other study ID #: TARGET AC
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: June 2022

Study information

• Verified date: December 2022
• Source: Shanghai MicroPort Medical (Group) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1653
• Est. completion date: June 2022
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Firehawk™ stent system
MicroPort Firehawk™ biodegradable polymer rapamycin target eluting stent
• Abbott Xience family Everolimus-Eluting Stent
Abbott Xience family Everolimus-Eluting Stent

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai MicroPort Medical (Group) Co., Ltd.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	In-stent late loss	In-stent late loss at 13 months post-procedure as measured by quantitative coronary angiography (QCA)	13 months
Secondary	stent struth Neointimal thickness	stent struth Neointimal thickness at 3 months measured by Optical Coherence Tomography (OCT)	3 months