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The First-In-Man Pilot Study of Firehawk

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rapamycin target-eluting Coronary Stent System
Sponsored by
Shanghai MicroPort Medical (Group) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Sirolimus eluting stents, percutaneous coronary intervention, First in man

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-75 years of age, males or non-pregnant females;
  2. With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
  3. Total number of target lesion is 1;
  4. Target lesion length ≤ 30mm (Visual); target lesion diameter between 2.25mm to 4.0mm;
  5. Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;
  6. Each target lesion may be covered by a single stent;
  7. Patients with indications for coronary artery bypass graft surgery;
  8. To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

Exclusion Criteria:

  1. Within 1 month of any acute myocardial infarction;
  2. Chronic total occlusion (TIMI grade 0 flow before surgery), left main coronary artery disease, mouth lesions, multiple-vessel lesions, branch diameter ≥ 2.5mm bifurcation lesions and vascular lesions of the bridge;
  3. Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
  4. In-stent Restenosis lesions;
  5. Intracoronary implantation of any branding stents within 1 year;
  6. Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or <40% (ultrasound or left ventricular angiography);
  7. Preoperative renal function serum creatinine >2.0mg/DL;
  8. 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;
  9. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
  10. The patient's life expectancy is less than 12 months;
  11. Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
  12. Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
  13. Heart transplantation patients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    treatment group

    Arm Description

    Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.

    Outcomes

    Primary Outcome Measures

    Count of Participants With MACE (Major Acute Cardiovascular Events)
    Count of Participants who have major acute cardiovascular events (MACE) in 1 month follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.

    Secondary Outcome Measures

    In-stent Late Lumen Loss
    In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 4 months follow-up in-stent minimal lumen diameter.
    Count of Participants With MACE (Major Acute Cardiovascular Events)
    Count of Participants who have major acute cardiovascular events (MACE) in 4 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.
    Percentage of In-stent Diameter Stenosis
    Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD-MLD)/RVD * 100%. RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease. MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest.
    In-stent Late Lumen Loss
    In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 13 months follow-up in-stent minimal lumen diameter.
    Count of Participants With MACE (Major Acute Cardiovascular Events)
    Count of Participants who have major acute cardiovascular events (MACE) in 13 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.
    Percentage of In-stent Diameter Stenosis
    Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD-MLD)/RVD * 100%. RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease. MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest.

    Full Information

    First Posted
    February 18, 2016
    Last Updated
    September 26, 2019
    Sponsor
    Shanghai MicroPort Medical (Group) Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02688829
    Brief Title
    The First-In-Man Pilot Study of Firehawk
    Official Title
    The Initial Small-Scale Clinical Study of Rapamycin-Eluting Coronary Stent System of Microport (Firehawk)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai MicroPort Medical (Group) Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a small-scale pilot clinical study of the Rapamycin-Eluting Coronary Stent System of Microport for the first time to assess the preliminary safety and feasibility used in the human body. And provide evidence for subsequent large-scale, multi-center, randomized controlled clinical trials, then provide the basis for the formal application of the product in China.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Heart Disease
    Keywords
    Sirolimus eluting stents, percutaneous coronary intervention, First in man

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment group
    Arm Type
    Experimental
    Arm Description
    Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.
    Intervention Type
    Device
    Intervention Name(s)
    Rapamycin target-eluting Coronary Stent System
    Other Intervention Name(s)
    Firehawk
    Intervention Description
    Implantation of the rapamycin-eluting coronary stent system
    Primary Outcome Measure Information:
    Title
    Count of Participants With MACE (Major Acute Cardiovascular Events)
    Description
    Count of Participants who have major acute cardiovascular events (MACE) in 1 month follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.
    Time Frame
    1 month after stent implantation
    Secondary Outcome Measure Information:
    Title
    In-stent Late Lumen Loss
    Description
    In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 4 months follow-up in-stent minimal lumen diameter.
    Time Frame
    4 months after stent implantation
    Title
    Count of Participants With MACE (Major Acute Cardiovascular Events)
    Description
    Count of Participants who have major acute cardiovascular events (MACE) in 4 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.
    Time Frame
    4 month after stent implantation
    Title
    Percentage of In-stent Diameter Stenosis
    Description
    Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD-MLD)/RVD * 100%. RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease. MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest.
    Time Frame
    4 months after stent implantation
    Title
    In-stent Late Lumen Loss
    Description
    In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 13 months follow-up in-stent minimal lumen diameter.
    Time Frame
    13 month after stent implantation
    Title
    Count of Participants With MACE (Major Acute Cardiovascular Events)
    Description
    Count of Participants who have major acute cardiovascular events (MACE) in 13 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.
    Time Frame
    13 month after stent implantation
    Title
    Percentage of In-stent Diameter Stenosis
    Description
    Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD-MLD)/RVD * 100%. RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease. MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest.
    Time Frame
    13 month after stent implantation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-75 years of age, males or non-pregnant females; With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction; Total number of target lesion is 1; Target lesion length ≤ 30mm (Visual); target lesion diameter between 2.25mm to 4.0mm; Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1; Each target lesion may be covered by a single stent; Patients with indications for coronary artery bypass graft surgery; To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up. Exclusion Criteria: Within 1 month of any acute myocardial infarction; Chronic total occlusion (TIMI grade 0 flow before surgery), left main coronary artery disease, mouth lesions, multiple-vessel lesions, branch diameter ≥ 2.5mm bifurcation lesions and vascular lesions of the bridge; Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery; In-stent Restenosis lesions; Intracoronary implantation of any branding stents within 1 year; Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or <40% (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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The First-In-Man Pilot Study of Firehawk

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