Status:
RECRUITING
Single Center Post-Market Study of Thrombolytic Therapy Using the Versus™ Catheter
Lead Sponsor:
Liquet Medical Inc.
Conditions:
Blood Clots
Vascular Disease
Eligibility:
All Genders
18-80 years
Brief Summary
Assess the functionality of the Versus Catheter for catheter-directed thrombolysis of pulmonary blood clots, including advanced imaging assessment. An evaluation of patient outcomes from the cases inc...
Detailed Description
The objective of this study is to assess the functionality of the Versus™ Catheter for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06975969
Start Date
September 5 2025
End Date
December 31 2025
Last Update
September 10 2025
Active Locations (1)
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1
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903