Single Center Post-Market Study of Thrombolytic Therapy Using the Versus™ Catheter

Liquet Medical Inc.

Status: Begins enrollment this month

Conditions: Embolism Thrombosis; Vascular Disease; Blood Clots; Lung Diseases; Cardiovascular Diseases

Treatments: Device: Versus™ Endovascular Pulmonary Artery Drug Delivery Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT06975969

CP-1001

1402 Liquet-UVA-VCU (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Patients who receive treatment using the Versus Catheter

Description:

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.

Treatment:

Device: Versus™ Endovascular Pulmonary Artery Drug Delivery Catheter