Deep Vein Thrombosis (DVT), Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts, Thrombus in the Peripheral Venous Vasculature, Venous Embolism
Conditions
Keywords
Aspiration Thrombectomy, Deep Vein Thrombosis (DVT), Peripheral VTE, Venous thromboembolism, Percutaneous mechanical thrombectomy
Brief 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). This prospective, multi-center, open-label study will assess clinical outcomes, device performance, and procedural success in a single DVT study cohort.
Interventions
DEVICEAspiration 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.
Sponsors
Argon Medical Devices
Avania
Medical Metrics Diagnostics, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all the following criteria to be eligible for the study: 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
Subjects will be excluded from the study if any of the following criteria are met: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | At the time of the index procedure | ≥75% thrombus removal in the target venous segment, assessed by change in Marder Score |
| Composite rate of Major Adverse Events (MAEs) within 30 days post-procedure | 30 days post-index procedure | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Device- or Procedure-Related Serious Adverse Events (SAEs) | 30 days post-procedure | — |
| Post-Thrombotic Syndrome Severity | Up to 24 months | 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. |
| Venous patency | From 30 days post-treatment to the end of the study period | Presence of flow in the treated venous segment without re-thrombosis |
| Need for Target Vessel Reintervention | From date of index procedure up to 24 months | Any additional endovascular or surgical procedure to address recurrent/residual thrombus |
| Numeric Pain Rating Scale | Up to 24 months | 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. |
Countries
United States
Contacts
CONTACTEsther Ajasa, MS
CONTACTHolly Harrison
STUDY_DIRECTORPete Stibbs
Argon Medical Devices
Outcome results
None listed