Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT04248868
Eligibility Criteria:
Inclusion Criteria:
1. Willing and able to provide informed consent;
2. Age 18 to ≤ 75 years of age;
3. PE symptom duration ≤ 14 days.
4. Filling defect in at least one main or lobar pulmonary artery as determined by contrast enhanced chest CT (CTA);
5. RV/LV diameter ratio ≥ 0.9 by CTA as determined by the investigative site;
6. Willing and able to comply with all study procedures and follow-up.
Exclusion Criteria:
1. CVA or TIA within one (1) year;
2. Head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study;
3. Active bleeding from a major organ within one (1) month prior to inclusion in the study;
4. Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
5. Patients with bleeding diatheses;
6. Hematocrit \< 30%;
7. Platelets \< 100,000/μL;
8. INR \> 1.5 if currently on warfarin (Coumadin®);
9. aPTT \> 50 seconds in the absence of anticoagulants;
10. Major surgery ≤ 14 days prior to inclusion in the study;
11. Serum creatinine \> 2.0mg/dL;
12. Clinician deems high-risk for catastrophic bleeding;
13. History of heparin-induced thrombocytopenia (HIT Syndrome);
14. Pregnancy;
15. SBP \< 90 mmHg \> 15 minutes within two (2) hours prior to BEC procedure and is not resolved with IV fluids;
16. Any vasopressor support;
17. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
18. Evidence of irreversible neurological compromise;
19. Life expectancy \< one (1) year;
20. Use of thrombolytics or glycoprotein IIb/IIIa inhibitor within 3 days prior to inclusion in the study;
21. Use of non-vitamin K oral anti-coagulants (NOACs), such as rivaroxaban (Xarelto®), apixaban (Eliquis®), dabigatran (Pradaxa®), edoxaban (Savaysa®) within 48 hours prior to inclusion in the study;
22. Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
23. Previous enrollment in this study;
24. Morbidly obese patient who by the judgement of the investigator is high risk for bleeding;
25. BMI \> 45kg/m2;
26. Absolute contraindication to anticoagulation;
27. Uncontrolled hypertension defined as SBP \> 175mmHg and / or DBP \> 110mmHg with pharmacotherapy within two (2) hours prior to inclusion in the study;
28. Currently participating in another study;
29. Any arterial line placement;
30. Current positive COVID diagnosis, or ≤ 8 weeks negative of COVID, or \> 8 weeks from positive COVID test and with current symptoms, or current active viral pneumonia on chest CT scan;
31. In the opinion of the investigator, the subject is not a suitable candidate for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04248868
Study Brief:
Protocol Section:
NCT04248868