N/A
Completed N=21
The First-In-Man Pilot Study of Firehawk
Source: ClinicalTrials.gov NCT02688829 ↗Enrolled (actual)
21
Serious AEs
9.5%
Results posted
Oct 2019
Primary outcomePrimary: Count of Participants With MACE (Major Acute Cardiovascular Events) — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants With MACE (Major Acute Cardiovascular Events) |
— | — |
| SECONDARY In-stent Late Lumen Loss |
0.16 | — |
| SECONDARY Count of Participants With MACE (Major Acute Cardiovascular Events) |
— | — |
| SECONDARY Percentage of In-stent Diameter Stenosis |
12.9 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT02688829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.