The First-In-Man Pilot Study of Firehawk

M

MicroPort

Status

Completed

Conditions

Coronary Heart Disease

Treatments

Device: Rapamycin target-eluting Coronary Stent System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02688829
Firehawk_FIM

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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