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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):
MicroPort Medical (Shanghai) Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01412164
First received: August 5, 2011
Last updated: April 10, 2012
Last verified: April 2012
History of Changes

August 5, 2011
April 10, 2012
August 2011
February 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01412164 on ClinicalTrials.gov Archive Site
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
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Coronary artery disease
Coronary Artery Disease
Device: FIREHAWK biodegradable polymer rapamycin-eluting stent
DES PCI for CAD
FIREHAWK DES
Using FIREHAWK DES treating CAD
Intervention: Device: FIREHAWK biodegradable polymer rapamycin-eluting stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
995
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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01412164
TARGET II
Yes
MicroPort Medical (Shanghai) Co. Ltd.
MicroPort Medical (Shanghai) Co. Ltd.
Not Provided
Principal Investigator: Runlin Gao, M.D., Prof. Beijing Fuwai Hospital
MicroPort Medical (Shanghai) Co. Ltd.
April 2012

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