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| ID | Type | Description | Link |
|---|---|---|---|
| 1402 Liquet-UVA-VCU | Other Grant/Funding Number | VBHRC Catalyst |
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No participants enrolled.
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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.
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 artery vasculature in adult patients, including advanced Computerized Tomography Angiogram (CTA) imaging assessment. This study will include an evaluation of patient outcomes and physician user experience with the Versus™ Catheter among up to 10 patients meeting the criteria for enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Versus™ Endovascular Pulmonary Artery Drug Delivery Catheter | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Clot resolution | Number of patients achieving hemodynamic homeostasis as evidenced by pulmonary artery pressure indicating resolution of a pulmonary blood clot | Within one week of hospital admission |
| Physician user experience | Number of physicians who rate use of the Versus Catheter as "Good & Acceptable" or "Very good & Acceptable" on a four-point scale | Periprocedural |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Luke Wilkins, MD | University of Virgina (UVA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Medical Center | Charlottesville | Virginia | 22903 | United States |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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