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
  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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:


Further study details as provided by MicroPort Medical (Shanghai) 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


Estimated Enrollment: 995
Study Start Date: August 2011
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
FIREHAWK DES
Using FIREHAWK DES treating 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Coronary artery disease

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
MicroPort Medical (Shanghai) Co. Ltd.
Investigators
Principal Investigator: Runlin Gao, M.D., Prof. Beijing Fuwai Hospital
  More Information

No publications provided

Responsible Party: MicroPort Medical (Shanghai) Co. Ltd.
ClinicalTrials.gov Identifier: NCT01412164     History of Changes
Other Study ID Numbers: TARGET II
Study First Received: August 5, 2011
Last Updated: April 10, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by MicroPort Medical (Shanghai) 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

ClinicalTrials.gov processed this record on September 29, 2014