Zakrzepica: badanie kliniczne

Kryteria wyłączenia kto nie może wziąć udziału (30)

1. Subjects must not meet any of the following general exclusion criteria:
2. Thrombolytic use within 30 days of baseline CT angiogram
3. Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization (site determined)
4. Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg;
5. FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%;
6. Hematocrit < 28%;
7. Platelets < 100,000/ML;
8. Serum creatinine > 1.8 mg/dL;
9. International normalized ratio (INR) > 3;
10. Major trauma injury severity score (ISS) > 15 within the past 14 days
11. Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months, Pacemaker or Implantable Cardioverter Defibrillators;
12. Cardiovascular or pulmonary surgery within last 7 days;
13. Actively progressing cancer requiring chemotherapy
14. Known bleeding diathesis or coagulation disorder;
15. Left bundle branch block;
16. History of severe or chronic pulmonary arterial hypertension;
17. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%;
18. History of uncompensated heart failure;
19. History of underlying lung disease that is oxygen dependent;
20. History of chest irradiation;
21. History of heparin-induced thrombocytopenia (HIT);
22. Patients who are under intubation
23. Any contraindication to systemic or therapeutic doses of heparin or anticoagulants;
24. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated;
25. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention;
26. Life expectancy of < 90 days, as determined by Investigator;
27. Female who is pregnant or nursing;
28. Current participation in another investigational drug or device treatment study
29. History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days
30. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis