Single Center Post-Market Study of Thrombolytic Therapy Using the Versus™ Catheter
NCT06975969 · Status: WITHDRAWN · Type: OBSERVATIONAL
Last updated 2026-03-05
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 included in this study will also be conducted.
Conditions
- Blood Clots
- Vascular Disease
- Embolism Thrombosis
- Cardiovascular Diseases
- Lung Diseases
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
Liquet Medical Inc.
lead INDUSTRY
Principal Investigators
-
Luke Wilkins, MD · University of Virgina (UVA)
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-05
- Primary Completion
- 2026-02-20
- Completion
- 2026-02-20
- FDA Device
- Yes
Countries
- United States
Study Locations
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