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

NCT06975969 | Withdrawn FDA Device

• 2 other identifiers: CP-10011402 Liquet-UVA-VCU
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

thrombolysis; pulmonary catheter; hemodynamic monitoring; catheter directed therapy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Device: Versus™ Endovascular Pulmonary Artery Drug Delivery Catheter

Interventions

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.

Patients who receive treatment using the Versus Catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liquet Medical Inc.: lead

Study Sites (1)

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Thrombosis; Vascular Diseases; Embolism and Thrombosis; Cardiovascular Diseases; Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Luke Wilkins, MD

  University of Virgina (UVA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 16, 2025
• Study Start: September 5, 2025
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)