Single Center Post-Market Study of Thrombolytic Therapy Using the Versus™ Catheter
NCT ID: NCT06975969
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10 participants
OBSERVATIONAL
2025-09-05
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients who receive treatment using the Versus Catheter
Patients age 18 - 80 years old who present with symptoms requiring intervention with delivery of physician-specified thrombolytics to the pulmonary vasculature, including patients who present with submassive pulmonary embolism (PE), who receive treatment using the Versus™ Catheter.
Versus™ Endovascular Pulmonary Artery Drug Delivery Catheter
The Versus Pulmonary Artery Catheter is a dual-tip, infusion catheter. Two lumens access and deliver physician-specified fluids, including thrombolytics, into the pulmonary arteries of each lung via a single access site. The Secondary Catheter tip telescopes independently to facilitate infusion into the contralateral lung. The device may allow for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Pressure is measured through an interface between the catheter's fluid lumen and an externally located, FDA-cleared, pressure transducer. The device may include an additional lumen that is in communication with a distal flow-directed balloon.
Interventions
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Versus™ Endovascular Pulmonary Artery Drug Delivery Catheter
The Versus Pulmonary Artery Catheter is a dual-tip, infusion catheter. Two lumens access and deliver physician-specified fluids, including thrombolytics, into the pulmonary arteries of each lung via a single access site. The Secondary Catheter tip telescopes independently to facilitate infusion into the contralateral lung. The device may allow for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Pressure is measured through an interface between the catheter's fluid lumen and an externally located, FDA-cleared, pressure transducer. The device may include an additional lumen that is in communication with a distal flow-directed balloon.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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Liquet Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Luke Wilkins, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virgina (UVA)
Locations
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University of Virginia Medical Center
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1402 Liquet-UVA-VCU
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CP-1001
Identifier Type: -
Identifier Source: org_study_id
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