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

Launched by LIQUET MEDICAL INC. · May 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medical device called the Versus™ Catheter, which is used to treat blood clots in the lungs, specifically a condition known as submassive pulmonary embolism (PE). The goal of the trial is to see how well this catheter works for delivering medication directly to the blood clots and to assess how patients respond to this treatment. Researchers will also use advanced imaging techniques to evaluate the effectiveness of the therapy and monitor patient outcomes.

To be eligible for this study, participants need to be between 18 and 80 years old and diagnosed with submassive pulmonary embolism that requires treatment. However, certain patients won't be able to join, such as those receiving other treatments for blood clots at the same time or those with severe bleeding disorders. If someone qualifies and decides to participate, they can expect to have the Versus™ Catheter used during their treatment and to be closely monitored for their progress. It's important to note that this trial is not yet recruiting participants, so there will be a bit of waiting before it starts.

Gender

ALL

Eligibility criteria

• 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