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The First-In-Man Pilot Study of Firehawk

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ClinicalTrials.gov Identifier: NCT02688829
Recruitment Status : Completed
First Posted : February 23, 2016
Results First Posted : October 17, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai MicroPort Medical (Group) Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Device: Rapamycin target-eluting Coronary Stent System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Initial Small-Scale Clinical Study of Rapamycin-Eluting Coronary Stent System of Microport (Firehawk)
Study Start Date : December 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: treatment group
Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.
Device: Rapamycin target-eluting Coronary Stent System
Implantation of the rapamycin-eluting coronary stent system
Other Name: Firehawk




Primary Outcome Measures :
  1. Count of Participants With MACE (Major Acute Cardiovascular Events) [ Time Frame: 1 month after stent implantation ]
    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 :
  1. In-stent Late Lumen Loss [ Time Frame: 4 months after stent implantation ]
    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.

  2. Count of Participants With MACE (Major Acute Cardiovascular Events) [ Time Frame: 4 month after stent implantation ]
    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.

  3. Percentage of In-stent Diameter Stenosis [ Time Frame: 4 months after stent implantation ]

    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.


  4. In-stent Late Lumen Loss [ Time Frame: 13 month after stent implantation ]
    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.

  5. Count of Participants With MACE (Major Acute Cardiovascular Events) [ Time Frame: 13 month after stent implantation ]
    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.

  6. Percentage of In-stent Diameter Stenosis [ Time Frame: 13 month after stent implantation ]

    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.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Shanghai MicroPort Medical (Group) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02688829     History of Changes
Other Study ID Numbers: Firehawk_FIM
First Posted: February 23, 2016    Key Record Dates
Results First Posted: October 17, 2019
Last Update Posted: October 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shanghai MicroPort Medical (Group) Co., Ltd.:
Sirolimus eluting stents
percutaneous coronary intervention
First in man
Additional relevant MeSH terms:
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Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs