Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking

NCT07102160 | Recruiting FDA Device

• 1 other identifier: CNPV01
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 3

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.

Conditions

Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts; Deep Vein Thrombosis (DVT); Thrombus in the Peripheral Venous Vasculature; Venous Embolism

Keywords

Aspiration Thrombectomy; Deep Vein Thrombosis (DVT); Peripheral VTE; Venous thromboembolism; Percutaneous mechanical thrombectomy

Outcome Measures

Primary Outcomes (2)

• Technical Success

  ≥75% thrombus removal in the target venous segment, assessed by change in Marder Score

  At the time of the index procedure

• Composite rate of Major Adverse Events (MAEs) within 30 days post-procedure

  30 days post-index procedure

Secondary Outcomes (5)

• Freedom from Device- or Procedure-Related Serious Adverse Events (SAEs)

  30 days post-procedure

• Post-Thrombotic Syndrome Severity

  Up to 24 months

• Venous patency

  From 30 days post-treatment to the end of the study period

• Need for Target Vessel Reintervention

  From date of index procedure up to 24 months

• Numeric Pain Rating Scale

  Up to 24 months

Study Arms (1)

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.

Device: Aspiration thrombectomy system

Interventions

Aspiration thrombectomy system DEVICE

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.

DVT Subgroup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medical Metrics Diagnostics, Inc: collaborator
• Argon Medical Devices: lead
• Avania: collaborator

Study Sites (3)

Baycare Health System

Tampa, Florida, 33607, United States

RECRUITING

St. Elizabeth Healthcare - Edgewood

Edgewood, Kentucky, 41017, United States

RECRUITING

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, 75093, United States

RECRUITING

Related Links

• Argon Medical Devices - CLEAR-VIEW XT study information

MeSH Terms

Conditions

Venous Thrombosis; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Study Officials

• Pete Stibbs

  Argon Medical Devices

  STUDY DIRECTOR

Central Study Contacts

Esther Ajasa, MS

CONTACT

469-423-2280; clinical@argonmedical.com

Holly Harrison

CONTACT

(469) 731-3561; clinical@argonmedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 3, 2025
• Study Start: February 4, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)