NCT06975969

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Liquet Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-05
• Primary completion: 2026-02-20
• Completion: 2026-02-20
• First posted: 2025-05-16
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study