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Completed

NCT Number: NCT02688868

Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 )

The purpose of this study is to evalute the clinical safety and effectiveness of released specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fu Wai Hospital

Beijing, Beijing Municipality, 100037, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-80 years of age, males or non-pregnant women;
  • Evidence of silent ischemia, stability or in patients with old myocardial infarction or unstable angina;
  • Primary target lesion, in situ coronary artery disease;
  • Target lesion length ≤ 60mm, target lesion diameter 2.25mm (Visual method);
  • The target lesion diameter stenosis ≥ 70% (Visual method);
  • Each target lesion implantation the same stent (Firehawk stent);
  • With indications for coronary artery bypass surgery;
  • To understand the purpose of testing, voluntary and informed consent, patients agreed to achieve invasive imaging and clinical follow-up.

Exclusion criteria

  • Within 72h of any acute myocardial infarction;
  • Unprotected left main coronary artery disease, triple vessel lesions which need treated all; bifurcation lesions and vascular lesions of the bridge;
  • Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
  • Artery and/or vein bypass graft lesions;
  • Intracoronary implantation of any branding stents within 1 year;
  • Severe congestive heart failure (NYHA class III and above), or left ventricular ejection fraction <35% (ultrasound or left ventricular angiography);
  • Preoperative renal function serum creatinine >2.0mg/DL;
  • Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
  • Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
  • The patient's life expectancy is less than 12 months;
  • Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
  • Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
  • Heart transplantation patients.

Treatment and study plan

FirehawkTM 2.25mm

Device

Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems

Primary outcomes

  1. In-stent Late Loss

    Time frame: 9 month after stent implantation

    the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure.

Secondary outcomes

  1. Number of Participants With Target Lesion Failure

    Time frame: 12 months

    including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization

  2. Number of Participants With Target Lesion Failure

    Time frame: 2 years

    including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization

  3. Number of Participants With Target Lesion Failure

    Time frame: 3 years

    including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization

  4. Number of Participants With Target Lesion Failure

    Time frame: 4 years

    including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization

  5. Number of Participants With MACE

    Time frame: 12 months

    a composite endpoint of all cause death, any myocardial infarction and any revascularization

  6. Number of Participants With MACE

    Time frame: 2 years

    a composite endpoint of all cause death, any myocardial infarction and any revascularization

  7. Number of Participants With MACE

    Time frame: 3 years

    a composite endpoint of all cause death, any myocardial infarction and any revascularization

  8. Number of Participants With MACE

    Time frame: 4 years

    a composite endpoint of all cause death, any myocardial infarction and any revascularization

Sponsors and collaborators

Lead sponsor

Shanghai MicroPort Medical (Group) Co., Ltd.

Industry

Registry information

Official study title

The Safety and Effectiveness Evaluation of New Specifications (2.25mm) of FirehawkTM Sirolimus Target-eluting Coronary Stent System in the Treatment of Coronary Heart Disease: a Prospective, Multicenter, Single-group Study.

Important dates

Study start
2014
Primary completion
2015
Study completion
2020
First posted
Feb 23, 2016
Registry last updated
Oct 23, 2023

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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