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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT04795167
Eligibility Criteria:
Inclusion Criteria:
Age \>=18 years Treatment team determines pulmonary embolism is the cause of shock, and the PE is high-risk per the protocol definitions
Exclusion Criteria:
* Out of hospital cardiac arrest with Glasgow Coma Scale of ≤8
* Witnessed cardiac arrest with ongoing CPR \>30 minutes
* Contraindication to anticoagulants, i.e. heparin or alternative
* Hematocrit \<28%
* Platelets \<25,000/μL
* INR \>8
* Intracardiac thrombus and/or intracardiac clot in transit
* Known anaphylactic sensitivity to radiographic agents that cannot be pre-treated
* History of pulmonary hypertension with systolic pulmonary arterial pressure \>70 mmHg
* Presence of chronic medical conditions with estimated \< 90 days life expectancy per physician discretion (should not consider the current pulmonary embolism and its treatment)
* Current participation in another drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
* Patient is known to be COVID-19 positive at hospital admission (patient has active COVID-19)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04795167
Study Brief:
Protocol Section:
NCT04795167