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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Shanghai MicroPort Medical (Group) Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01412164

First received: August 5, 2011

Last updated: February 19, 2016

Last verified: February 2016

History of Changes

Purpose

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	Intervention
Coronary Artery Disease	Device: FIREHAWK biodegradable polymer rapamycin-eluting stent


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by Shanghai MicroPort Medical (Group) Co., Ltd.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Stent Implantation Success Rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
30 days, 6 months, and 2-5 years TLF, cardiovascular composite endpoints, ARC defined stent thrombosis


Enrollment:	730
Study Start Date:	August 2011
Estimated Study Completion Date:	February 2017
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Firehawk Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD	Device: FIREHAWK biodegradable polymer rapamycin-eluting stent DES PCI for CAD

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.

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412164

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

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
Study First Received:	August 5, 2011
Results First Received:	February 19, 2016
Last Updated:	February 19, 2016
Health Authority:	China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016

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