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

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)

Overview

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

• Device 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.

Primary outcome measures

• Technical Success [Time frame: At the time of the index procedure]
• Composite rate of Major Adverse Events (MAEs) within 30 days post-procedure [Time frame: 30 days post-index procedure]

Secondary outcome measures (5)

• Freedom from Device- or Procedure-Related Serious Adverse Events (SAEs) [Time frame: 30 days post-procedure]
• Post-Thrombotic Syndrome Severity [Time frame: Up to 24 months]
• Venous patency [Time frame: From 30 days post-treatment to the end of the study period]
• Need for Target Vessel Reintervention [Time frame: From date of index procedure up to 24 months]
• Numeric Pain Rating Scale [Time frame: Up to 24 months]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 4 centers

• Janna, LLC — Fort Lauderdale
• Baycare Health System — Tampa
• St. Elizabeth Healthcare - Edgewood — Edgewood
• Baylor Scott & White The Heart Hospital - Plano — Plano

Identifiers

NCT: NCT07102160 · CNPV01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗