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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT03218566
Eligibility Criteria:
Inclusion Criteria:
* Clinical signs and symptoms consistent with acute PE with duration of 14 days or less. Evidence of PE must be from CTA.
* Systolic BP ≥ 90 mmHg with evidence of dilated RV with an RV/LV ratio \> 0.9
* Patient is 18 years of age or older
Exclusion Criteria:
* tPA use within 14 days prior to baseline CTA
* Systolic BP \< 90mmHg for 15min or the requirement of inotropic support to maintain systolic BP ≥ 90 mmHg
* Pulmonary hypertension with peak PA \> 70 mmHg by right heart catheterization
* History of severe or chronic pulmonary hypertension
* Fi02 requirement \> 40% or \>6 LPM to keep oxygen saturations \>90%
* Hematocrit \< 28%
* Platelets \< 100,000µL
* Serum creatinine \> 1.8 mg/dL
* INR \> 3
* aPTT (or PTT) \> 50 seconds on no anticoagulation
* History of heparin-induced thrombocytopenia (HIT)
* Contraindication to systemic or therapeutic doses of anticoagulants
* Major trauma \< 14 days
* Presence of intracardiac lead
* Cardiovascular or pulmonary surgery within last 7 days
* Cancer requiring active chemotherapy
* Known serious, uncontrolled sensitivity to radiographic agents
* Life expectancy \< 90 days
* Female who is pregnant
* Intracardiac Thrombus
* Patients on ECMO
* Current participation in another investigational study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03218566
Study Brief:
Protocol Section:
NCT03218566