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Completed

NCT Number: NCT01412164

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 diameter 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

  • Acute 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, rapamycin and metal
  • Life expectation <12 months
  • History of not achieving study finish
  • No compliances to the protocol
  • Heart implantation subjects

Treatment and study plan

FIREHAWK biodegradable polymer rapamycin-eluting stent

Device

DES PCI for CAD

Primary outcomes

  1. TLF (Target Lesion Failure) Rate

    Time frame: 12 months after index procedure

    Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR

Secondary outcomes

  1. Stent Implantation Success Rate (SIS Rate)

    Time frame: immediately after the procedure

    Stent implantation success (SIS) means participant successfully implanted stent, defined as residual stenosis of the lesion less than 30% and TIMI bloodflow Grade III

  2. Patient-related Cardiovascular Clinical Composite Endpoints

    Time frame: 1 years after index PCI

    Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.

  3. Patient-related Cardiovascular Clinical Composite Endpoints

    Time frame: 3 years after index PCI

    Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.

  4. Patient-related Cardiovascular Clinical Composite Endpoints

    Time frame: 5 years after index PCI

    Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.

  5. TLF (Target Lesion Failure)

    Time frame: 1 years after index PCI

    Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR

  6. TLF (Target Lesion Failure)

    Time frame: 3 years after index PCI

    Participants with the determination of TLF, TLF is the composite of cardiac death, target vessel MI and clinically driven TLR

  7. TLF (Target Lesion Failure)

    Time frame: 5 years after index PCI

    Participants with the determination of TLF. TLF is the composite of cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure

Sponsors and collaborators

Lead sponsor

Shanghai MicroPort Medical (Group) Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2017
First posted
Aug 9, 2011
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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