Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
NCT ID: NCT07102160
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
185 participants
OBSERVATIONAL
2026-01-31
2029-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Aspiration thrombectomy system
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.
Interventions
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Aspiration thrombectomy system
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.
Eligibility Criteria
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Inclusion Criteria
1. At least 18 years of age at the time of consent.
2. Undergo frontline (primary) treatment with Cleaner Vac® Thrombectomy System in the peripheral venous vasculature and have at least one component introduced into the body.
3. 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:
4. Present with unilateral or bilateral lower extremity DVT involving at least one of the following veins:
1. Femoral-popliteal vein
2. Common femoral vein
3. Iliac vein
4. Inferior Vena Cava (IVC)
5. DVT diagnosis confirmed by imaging within 14 days of the index procedure.
6. Symptomatic DVT with onset within 6 weeks of enrollment.
Exclusion Criteria
1. Contraindication to systemic or therapeutic doses of anticoagulants.
2. Contraindication to iodinated contrast that cannot be adequately premedicated.
3. Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment
4. Patients that are pregnant.
5. 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.
6. Treatment of target venous segment with thrombolytics within previous 14 days of the index procedure.
7. Known congenital anatomic anomalies of the inferior vena cava (IVC) or iliac veins.
8. Known history of a Patent Foramen Ovale (PFO).
9. Hemoglobin \< 8.0 g/dL, INR \> 2.0 before warfarin was started, or platelets \< 50,000/µl which cannot be corrected prior to enrollment.
10. 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.
11. Patients with intermediate-high risk or high-risk pulmonary embolism (PE) defined as follows:
1. 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)
2. Intermediate-high-risk PE: Hemodynamically stable patients with both right ventricular (RV) dysfunction (on echocardiography or CT) and elevated cardiac biomarkers (e.g., troponin).
12. Complete infrarenal IVC occlusion.
13. Chronic non-ambulatory status.
14. 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.
18 Years
ALL
No
Sponsors
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Avania
INDUSTRY
Medical Metrics Diagnostics, Inc
INDUSTRY
Argon Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Danyel Carr, MS
Role: STUDY_DIRECTOR
Argon Medical Devices
Pete Stibbs, MD, MSc, MBA
Role: STUDY_DIRECTOR
Argon Medical Devices
Locations
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Baycare Health System
Tampa, Florida, United States
St. Elizabeth Healthcare - Edgewood
Edgewood, Kentucky, United States
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Argon Medical Devices - CLEAR-VIEW XT study information
Other Identifiers
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CNPV01
Identifier Type: -
Identifier Source: org_study_id
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