Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking (NCT07102160) | Clinical Trial Compass
RecruitingNot Applicable
Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
United States185 participantsStarted 2026-02-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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)
Exclusion criteria
✕. 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.
What they're measuring
1
Technical Success
Timeframe: At the time of the index procedure
2
Composite rate of Major Adverse Events (MAEs) within 30 days post-procedure