Deep Vein Thrombosis (DVT)CLEAR-VIEW XTNCT07102160
Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
An observational study of Deep Vein Thrombosis (DVT) and Thrombus in the Peripheral Venous Vasculature, run by Argon Medical Devices at 4 sites in United States.
Trial summary
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the Cleaner Vac® Thrombectomy System for the treatment of thrombus in patients with lower extremity proximal deep vein thrombosis (DVT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis (DVT), Thrombus in the Peripheral Venous Vasculature, Venous Embolism
- What is being tested?
- Aspiration thrombectomy system
- Type of treatment
- Medical device
- How many people
- 185 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Feb 2026to Jun 2029
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll up to 185 adult participants undergoing percutaneous mechanical thrombectomy using the Cleaner Vac® Thrombectomy System for the treatment of thrombus in the peripheral venous vasculature. Participants must be at least 18 years old and undergoing frontline treatment with the Cleaner Vac® device. The DVT subgroup must have symptomatic, imaging-confirmed DVT involving the femoral-popliteal, common femoral, iliac veins, or inferior vena cava (IVC), with symptom onset within 6 weeks and imaging confirmation within 14 days of the index procedure. The study population is intended to reflect a real-world, all-comers cohort treated across up to 50 investigational sites in the United States.
Who may be able to join
- Participants must meet all the following criteria to be eligible for the study:
- At least 18 years of age at the time of consent.
- Undergo frontline (primary) treatment with Cleaner Vac® Thrombectomy System in the peripheral venous vasculature and have at least one component introduced into the body.
- Written informed consent obtained through the IRB-approved ICF.
- For the DVT cohort, participants must meet all criteria above and below to be eligible for the study:
- Present with unilateral or bilateral lower extremity DVT involving at least one of the following veins:
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- Femoral-popliteal vein
- Common femoral vein
- Iliac vein
- Inferior Vena Cava (IVC)
- DVT diagnosis confirmed by imaging within 14 days of the index procedure.
- Symptomatic DVT with onset within 6 weeks of enrollment.
Who cannot join
- Subjects will be excluded from the study if any of the following criteria are met:
- Contraindication to systemic or therapeutic doses of anticoagulants.
- Contraindication to iodinated contrast that cannot be adequately premedicated.
- Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment
- Patients that are pregnant.
- Known coagulation disorders both acquired (Heparin Induced Thrombocytopenia, etc.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period.
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- Treatment of target venous segment with thrombolytics within previous 14 days of the index procedure.
- Known congenital anatomic anomalies of the inferior vena cava (IVC) or iliac veins.
- Known history of a Patent Foramen Ovale (PFO).
- Hemoglobin < 8.0 g/dL, INR > 2.0 before warfarin was started, or platelets < 50,000/µl which cannot be corrected prior to enrollment.
- Severe renal impairment (estimated GFR < 30 ml/min) in patients who are not yet on dialysis. Patients with GFR <30 ml/min who are already on dialysis can be enrolled.
- Patients with intermediate-high risk or high-risk pulmonary embolism (PE) defined as follows:
- High-risk PE: Presence of hemodynamic instability, including cardiac arrest, obstructive shock (systolic blood pressure <90 mmHg or need for vasopressors with signs of end-organ hypoperfusion), or persistent hypotension (systolic BP <90 mmHg or a drop ≥40 mmHg for >15 minutes not due to other causes)
- Intermediate-high-risk PE: Hemodynamically stable patients with both right ventricular (RV) dysfunction (on echocardiography or CT) and elevated cardiac biomarkers (e.g., troponin).
- Complete infrarenal IVC occlusion.
- Chronic non-ambulatory status.
- Current enrollment in another investigational device or drug study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
St. Elizabeth Healthcare - Edgewood
Edgewood, Kentucky, 41017
Alisha Hartmann, Alisha.Hartmann@stelizabeth.com
Alexander H Hou, MD
- Recruiting
Janna, LLC
Fort Lauderdale, Florida, 33316
Vicky Rodriguez, 954-616-1916, wtamimmd@hotmail.com
Wael Tamim, MD
- Recruiting
Indiana University Health
Indianapolis, Indiana, 46202
Siji Mathachan, 317-963-4786, simath@iu.edu
Eric Grubbs, eegrubbs@iu.edu
- Recruiting
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093
Erika V Ortiz, BA, 469-814-4977, Erika.Ortiz1@BSWHealth.org
Osniel V Ramos, 469-814-4862, Osniel.gonzalezramos@bswhealth.org
About this study
Official title: A Prospective, Multi-Center, Open-Label Clinical Investigation of the Cleaner Vac® Thrombectomy System for Treatment of Lower Extremity Proximal Deep Vein Thrombosis (DVT)
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the Cleaner Vac® Thrombectomy System for the treatment of thrombus in patients with lower extremity proximal deep vein thrombosis (DVT). This prospective, multi-center, open-label study will assess clinical outcomes, device performance, and procedural success in a single DVT study cohort.
- Conditions
- Deep Vein Thrombosis (DVT), Thrombus in the Peripheral Venous Vasculature, Venous Embolism, Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts
- Being tested
- Aspiration thrombectomy system
- Keywords
- Aspiration Thrombectomy, Deep Vein Thrombosis (DVT), Peripheral VTE, Venous thromboembolism, Percutaneous mechanical thrombectomy
- Medical subject headings
- Venous Thrombosis, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration thrombectomy systemDevice
The Cleaner Vac® Thrombectomy System is a percutaneous mechanical aspiration thrombectomy device designed for the removal of fresh, soft thrombi and emboli from the peripheral venous vasculature. The system includes an aspiration canister with integrated pump, an 18F aspiration catheter, a handpiece with aspiration control lever, a dilator, and an optional flushing adapter. The device operates via controlled suction to extract thrombus and restore venous patency.
| Study group | Role | What they receive |
|---|---|---|
| DVT Subgroup | This is a defined cohort focused on patients with lower extremity proximal deep vein thrombosis (DVT) who will undergo treatment with Cleaner Vac® Thrombectomy System. Participants will complete required follow-up at discharge and at 1, 6, 12, and 24 months. Receives: Device: Aspiration thrombectomy system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
≥75% thrombus removal in the target venous segment, assessed by change in Marder Score
Measured: At the time of the index procedure
Composite rate of Major Adverse Events (MAEs) within 30 days post-procedure
Measured: 30 days post-index procedure
Secondary outcomes (5)
Freedom from Device- or Procedure-Related Serious Adverse Events (SAEs)
Measured: 30 days post-procedure
Post-Thrombotic Syndrome Severity
Assessment of post-thrombotic syndrome using the Villalta score, which combines patient-reported symptoms and clinician-assessed signs to generate a composite score. A score ≥5 indicates the presence of post-thrombotic syndrome, with higher scores reflecting greater severity.
Measured: Up to 24 months
Venous patency
Presence of flow in the treated venous segment without re-thrombosis
Measured: From 30 days post-treatment to the end of the study period
Need for Target Vessel Reintervention
Any additional endovascular or surgical procedure to address recurrent/residual thrombus
Measured: From date of index procedure up to 24 months
Numeric Pain Rating Scale
Self-reported health status measured using the Numeric Pain Rating Scale questionnaire, which evaluates current, best, and worst pain experienced on a 0 (minimum) to 10 (maximum) level scale. 10 having worst pain imaginable.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start4 Feb 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis (DVT)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Argon Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania, Medical Metrics Diagnostics, Inc
- Responsible party
- Sponsor
- Investigators
- Pete Stibbs, Study director, Argon Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102160
- Sponsor's protocol ID
- CNPV01
- Acronym
- CLEAR-VIEW XT
- Status last verified
- Oct 2026
- First submitted
- 11 Jul 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No