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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
  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:

U.S. FDA Resources

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
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
Sirolimus
Everolimus
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 18, 2013