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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT06975969
Eligibility Criteria:
Inclusion Criteria:
* Patients 18 - 80 years, inclusive
* Patients who present with submassive pulmonary embolism (PE)
* Patients requiring thrombolytic intervention to the pulmonary vasculature
* Physician decision to use the Versus™ Catheter during the treatment of the patient
Exclusion Criteria:
* Concurrent treatment with thrombectomy
* Concurrent treatment with a catheter-directed thrombolysis device that is NOT the Versus™ Catheter
* Massive pulmonary embolism (PE)
* Active bleeding disorder1
* Recent cerebrovascular accident or transient ischemic attack1
* Recent neurosurgery1
* Recent intracranial trauma1
* Absolute contraindication to anticoagulation1
* BMI \> 45kg/m2
* In the opinion of the investigator, the participant is not a suitable candidate for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06975969
Study Brief:
Protocol Section:
NCT06975969