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N/A Completed N=38 Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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