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:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT06310018
Eligibility Criteria:
Inclusion Criteria:
1. patients at least 18 years of age,
2. symptomatic PE defined as symptoms for \<14 days with normal systolic blood pressure (\>90 mmHg), RV-to-LV diameter ratio ≥0.9 on initial chest CT, bilateral filling defects located in at least 1 main or proximal lobar pulmonary artery, and cardiac troponin greater than the upper limit of normal (cTnI, cTnT, hsTnI, or hsTnT), AND
3. in whom ultrasound-facilitated, catheter-directed lower-dose fibrinolysis has been selected for treatment on a clinical basis.
Exclusion Criteria:
1. stroke or transient ischemic attack, head trauma, other active intracranial or intraspinal disease (including malignancy) within 1 year
2. recent active bleeding from a major organ within 1 month
3. major surgery within 7 days of screening
4. contraindication to therapeutic anticoagulation
5. systolic blood pressure \<90 mm Hg, systolic blood pressure drop by at least 40 mmHg over at least 15 minutes, shock, use of vasopressors, need for CPR, or need for ECMO
6. need for mechanical ventilation, including non-invasive positive pressure ventilation
7. hematocrit \<30%, platelet count \<100,000/μl
8. international normalized ratio \>3
9. serum creatinine \> 2 mg/dL
10. liver cirrhosis
11. known hypersensitivity to tPA, heparin, or any excipients
12. perceived high risk for fatal or catastrophic bleeding
13. prescription of dual antiplatelet therapy (DAPT) at time of screening
14. Patients treated with any other advanced therapy, such as surgical embolectomy, catheter-based mechanical embolectomy, or fibrinolytic therapy, within the prior 30 days
15. pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06310018
Study Brief:
Protocol Section:
NCT06310018