N/A
Completed N=38
Evaluation of New Specifications (38mm) of FirehawkTM in the Treatment of Coronary Heart Disease
Source: ClinicalTrials.gov NCT02688842 ↗Enrolled (actual)
38
Serious AEs
39.5%
Results posted
Feb 2020
Primary outcomePrimary: In-stent Late Lumen Loss — 0.19 mm
Summary
The purpose of this study is to evalute the clinical safety and effectiveness of released specification (38mm) of FirehawkTM Sirolimus target-eluting coronary stent system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-stent Late Lumen Loss |
0.19 | — |
| SECONDARY Participants With Target Lesion Failure |
2 | — |
| SECONDARY Major Adverse Cardiac Events |
7 | — |
Eligibility Criteria
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 2.75mm or 4.0mm (Visual method);
- The target lesion diameter stenosis ≥ 70% (Visual method);
- Each target lesion implantation the same stent (Firehawk stand);
- With indications for coronary artery bypass surgery;
- To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
Exclusion Criteria
- Within 72h of any acute myocardial infarction;
- Unprotected left main coronary artery disease, triple vessel lesions which need treated all;
- 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 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 (NCT02688842). 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.