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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT02396758
Eligibility Criteria:
Inclusion Criteria:
1. Male or female greater than or equal to (≥) 18 years of age and less than or equal to (≤) 75 years of age.
2. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery).
3. PE symptom duration ≤14 days.
4. Submassive PE: RV/LV diameter ≥ 0.9 from CTA and hemodynamically stable. For Participants in UK Sites: Submassive PE: RV/LV diameter ≥ 0.9 from CTA, hemodynamically stable and an elevated biomarker.
5. Must be treated within 48 hours of diagnosis of PE by CTA.
6. Signed Informed consent obtained from subject or Legally Authorized Representative.
Exclusion Criteria:
1. Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year.
2. Recent (within one month) or active bleeding from a major organ.
3. Major surgery within seven days of screening for study enrollment.
4. Clinician deems the subject high-risk for catastrophic bleeding.
5. History of heparin-induced thrombocytopenia (HIT).
6. Catheter-based pharmacomechanical treatment for PE within 3 days of study enrollment.
7. Systolic blood pressure (SBP) less than 90 mm Hg and/or use of vasopressors.
8. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR).
9. Evidence of irreversible neurological compromise.
10. Life expectancy \< one year. For Participants in UK Sites: Life expectancy \< one year or enrollment in hospice care.
11. Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study.
12. Out-of-Range Laboratory Values: Hematocrit \< 30%, Platelets \< 100 thousand/microliter (μL), International normalized ratio (INR) \> 3.
13. Creatinine outside the normal range for the treating institution.
14. Participant is pregnant (positive pregnancy test; women of childbearing capacity must be tested) or breast feeding.
15. Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: participants with non-melanoma primary skin cancers are eligible to participate in the study.
16. Known allergy, hypersensitivity, or thrombocytopenia from heparin, r-tPA, or iodinated contrast except for mild-moderate contrast allergies for which steroid pre-medication can be used.
17. History of any hematologic disease potentially involving abnormal platelet number or function.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02396758
Study Brief:
Protocol Section:
NCT02396758