Blood Clots, Cardiovascular Diseases, Embolism Thrombosis, Lung Diseases, Vascular Disease
Conditions
Keywords
thrombolysis, pulmonary catheter, hemodynamic monitoring, catheter directed therapy
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 included in this study will also be conducted.
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 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.
Interventions
DEVICEVersus™ 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
Liquet Medical Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Clot resolution | Within one week of hospital admission | Number of patients achieving hemodynamic homeostasis as evidenced by pulmonary artery pressure indicating resolution of a pulmonary blood clot |
| Physician user experience | Periprocedural | Number of physicians who rate use of the Versus Catheter as "Good \& Acceptable" or "Very good \& Acceptable" on a four-point scale |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLuke Wilkins, MD
University of Virgina (UVA)
Outcome results
None listed