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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT03854266
Eligibility Criteria:
Inclusion Criteria:
* Age \> 17 and \< 81 years
* Debut of symptoms \<14 days
* Acute symptomatic Intermediate-high risk pulmonary embolism (PE, according to 2014 European Society of Cardiology guidelines) confirmed by computed tomography angiography (CTA) with the embolus located in at least one proximal lower lobe or main pulmonary artery.
* Right-to-left ventricular dimension ratio \>1.0 on CTA or trans-thoracic echocardiography (TTE)
Exclusion Criteria:
* Significant bleeding risk or other contraindications to catheter directed thrombolysis (CDT) or unfractionated heparin\*
* Not possible to perform CDT within 48 hours after diagnosis
* Pregnancy
* Cardiac arrest requiring cardiopulmonary resuscitation
* Life expectancy \< 120 days
* Altered mental status such that the patient is unable to provide informed consent
* Suspected or known chronic thromboembolic pulmonary hypertension
* Sustained hypertension (\>180 mmHg systolic and/or \>105 mmHg diastolic)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03854266
Study Brief:
Protocol Section:
NCT03854266