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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01412164
Recruitment Status : Unknown
Verified February 2016 by Shanghai MicroPort Medical (Group) Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : August 9, 2011
Results First Posted : March 17, 2016
Last Update Posted : March 17, 2016
Information provided by (Responsible Party):
Shanghai MicroPort Medical (Group) Co., Ltd.

August 5, 2011
August 9, 2011
February 19, 2016
March 17, 2016
March 17, 2016
August 2011
February 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01412164 on Archive Site
Stent Implantation Success Rate [ Time Frame: 5 years ]
30 days, 6 months, and 2-5 years TLF, cardiovascular composite endpoints, ARC defined stent thrombosis
Same as current
Not Provided
Not Provided
Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)
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
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.
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.
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
Device: FIREHAWK biodegradable polymer rapamycin-eluting stent
Experimental: Firehawk
Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD
Intervention: Device: FIREHAWK biodegradable polymer rapamycin-eluting stent
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
February 2017
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Shanghai MicroPort Medical (Group) Co., Ltd.
Shanghai MicroPort Medical (Group) Co., Ltd.
Not Provided
Principal Investigator: Runlin Gao, M.D., Prof. Fu Wai Hospital, Beijing, China
Shanghai MicroPort Medical (Group) Co., Ltd.
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP