Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The study aims to further assess the safety, efficacy and the performance of its delivery system of FIREHAWK rapamycin-eluting stent up to five years.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Device: FIREHAWK biodegradable polymer rapamycin-eluting stent	Not Applicable

Detailed Description:

This is a prospective open-labeled, multi-center, single-arm observational registry study. Approximately 1,100 subjects will be enrolled to evaluate the TLF as the primary endpoint at 12-month. Also, the study will follow up those subjects up to 5 years as the secondary endpoints.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	730 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Prospective Multicenter Single-Arm Observational Registry Study Assessing the Safety and Efficacy of FIREHAWK Biodegradable Polymer Target-release Rapamycin-eluting Stent for the Treatment of Coronary Artery Disease: TARGET II
Study Start Date :	August 2011
Actual Primary Completion Date :	February 2013
Estimated Study Completion Date :	February 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Firehawk; Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD	Device: FIREHAWK biodegradable polymer rapamycin-eluting stent; DES PCI for CAD

Outcome Measures

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Primary Outcome Measures :

1. Device Related Cardiovascular Composite Endpoint [ Time Frame: 12 months ]
   Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure

Secondary Outcome Measures :

1. Stent Implantation Success Rate [ Time Frame: 5 years ]
   30 days, 6 months, and 2-5 years TLF, cardiovascular composite endpoints, ARC defined stent thrombosis

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Age 18-75, male or unpregnant women
• Evidence of non-symptomatic ischemia, stable or non-stable angina or past MI
• Native coronary artery target lesion
• Target lesion length <=60mm, target lesion vessel diameter 2.25mm-4.0mm
• Target lesion diamter stenosis>=70%
• For each target lesion, Firehawk stent implantation only
• Understand the study purpose, willing to participate and sign the letter of consent
• Acceptance of clinical follow-up

Exclusion Criteria:

• Actue MI within 72 hours
• Unprotected LM and intervention-required three-vessel lesions
• Calcified lesion failed in pre-dilation and twisted lesion
• Bridge vessel lesion
• Any stent implanted within one year
• Severe heart failure (HYHA>=III) or LVEF<40%
• Renal deficiency, blood creatinine > 2.0mg/dl
• Bleeding tendency
• Allergic to aspirin, clopidogrel, ticlopidine, dye, ramapycin and metal
• Life expectation <12 months
• History of not achieving study finish
• No compliances to the protocol
• Heart implantation subjects

Contacts and Locations

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Locations

China
Fuwai Hospital
Beijing, China

Sponsors and Collaborators

Shanghai MicroPort Medical (Group) Co., Ltd.

Investigators

Principal Investigator:	Runlin Gao, M.D., Prof.	Fu Wai Hospital, Beijing, China

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gao Z, Zhang R, Xu B, Yang Y, Ma C, Li H, Chen S, Han Y, Yuan Z, Lansky AJ, Guan C, Leon MB, Gao R; TARGET Investigators. Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: two-year results from a prospective patient-level pooled analysis of TARGET trials. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:734-43. doi: 10.1002/ccd.25861. Epub 2015 Feb 19.

Responsible Party:	Shanghai MicroPort Medical (Group) Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01412164 History of Changes
Other Study ID Numbers:	TARGET II
First Posted:	August 9, 2011
Results First Posted:	March 17, 2016
Last Update Posted:	March 17, 2016
Last Verified:	February 2016

Keywords provided by Shanghai MicroPort Medical (Group) Co., Ltd.:

DES; CAD; FIREHAWK; MicroPort; PCI

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Sirolimus	Everolimus; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs