Blood ClotsNCT06975969
Single Center Post-Market Study of Thrombolytic Therapy Using the Versus™ Catheter
An observational study of Blood Clots and Vascular Disease, run by Liquet Medical Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Clots, Vascular Disease, Embolism Thrombosis
- What is being tested?
- Versus™ Endovascular Pulmonary Artery Drug Delivery Catheter
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2025to 20 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Medical Center
Charlottesville, Virginia, 22903
About this study
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.
Read the 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
- Being tested
- Versus™ Endovascular Pulmonary Artery Drug Delivery Catheter
- Keywords
- thrombolysis, pulmonary catheter, hemodynamic monitoring, catheter directed therapy
- Medical subject headings
- Thrombosis, Vascular Diseases, Embolism and Thrombosis, Cardiovascular Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Versus™ Endovascular Pulmonary Artery Drug Delivery CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Versus™ Endovascular Pulmonary Artery Drug Delivery Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Clot resolution
Number of patients achieving hemodynamic homeostasis as evidenced by pulmonary artery pressure indicating resolution of a pulmonary blood clot
Measured: 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
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start5 Sep 2025
- Primary completion20 Feb 2026
- Study completion20 Feb 2026
Why it stopped: No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood ClotsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liquet Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luke Wilkins, MD, Principal investigator, University of Virgina (UVA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975969
- Sponsor's protocol ID
- CP-1001
- Other IDs
- 1402 Liquet-UVA-VCU
- Status last verified
- Mar 2026
- First submitted
- 23 Apr 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Post-Market Study of Thrombolytic Therapy Using the Versus™ Catheter
- ClinicalTrials.gov ID
- NCT06975969
- Acronym / sponsor ID
- CP-1001
- Conditions
- Blood Clots, Vascular Disease, Embolism Thrombosis, Cardiovascular Diseases, Lung Diseases
- Keywords
- thrombolysis, pulmonary catheter, hemodynamic monitoring, catheter directed therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Liquet Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who receive treatment using the Versus Catheter | – | Device: Versus™ Endovascular Pulmonary Artery Drug Delivery CatheterPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Versus™ Endovascular Pulmonary Artery Drug Delivery CatheterThe 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. | Device | Patients who receive treatment using the Versus Catheter |
Primary outcome
Blood Clot resolution
Time frame: 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
Time frame: Periprocedural
Number of physicians who rate use of the Versus Catheter as "Good \& Acceptable" or "Very good \& Acceptable" on a four-point scale
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke Wilkins, MD principal investigator
University of Virgina (UVA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Clots and Vascular Disease, run by Liquet Medical Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Clot resolution (time frame: Within one week of hospital admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.