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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01412164
First Posted: August 9, 2011
Last Update Posted: March 17, 2016
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.
Information provided by (Responsible Party):
Shanghai MicroPort Medical (Group) Co., Ltd.
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Stent Implantation Success Rate [ Time Frame: 5 years ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):
Responsible Party: Shanghai MicroPort Medical (Group) Co., Ltd.
ClinicalTrials.gov Identifier: NCT01412164     History of Changes
Other Study ID Numbers: TARGET II
First Submitted: August 5, 2011
First Posted: August 9, 2011
Results First Submitted: February 19, 2016
Results First Posted: March 17, 2016
Last Update Posted: March 17, 2016
Last Verified: February 2016

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