ARC-VAC Study (Analysis of Real-world multicenter experience with large bore Cleaner-VAC thrombectomy system), an analysis of 200 patients

BACKGROUND: Venous thromboembolism (VTE), encompassing deep vein thrombosis (DVT) and pulmonary embolism (PE), represents a significant clinical entity with elevated morbidity and mortality rates. Conventional therapeutic approaches, such as systemic anticoagulation and thrombolytic agents, frequently yield suboptimal thrombus resolution. Mechanical thrombectomy has introduced a paradigm shift, enabling expeditious thrombus extraction while mitigating the chronic outcomes of sub optimally treated VTE and sequelae inherent to fibrinolytic therapies. The CLEANER Vac™ Thrombectomy System (Argon Medical Devices) is designed for controlled percutaneous venous thrombectomy. OBJECTIVE: To evaluate the real-world procedural efficacy, safety profile, and clinical utility of the CLEANER Vac system in a multicenter cohort comprising 200 patients presenting with symptomatic venous thrombus. METHODS: This retrospective, multicenter investigation included data from 200 patients who underwent intervention between October 2024 and January 2026 across 26 U.S. institutions. Eligible participants were adults aged ≥18 years with imaging-confirmed acute (<14 days) or subacute (14-28 days) VTE. Primary endpoints included thrombus clearance efficacy, segmented venous involvement, estimated blood loss (EBL), and intraprocedural adverse event incidence. RESULTS: The study cohort had a mean age of 64.5 years (range 25-90 years), with a gender distribution of 52% female (n=104) and 48% male (n=96). An average of 2.2 venous segments were treated per patient (range 1-5). Mean pre-procedure clot burden was 88.0%, which decreased to 10.5% post-procedure, culminating in a mean thrombus clearance of 88.0%. Overall, 76.0% of patients (n=152) achieved ≥90% clot resolution. Adjunctive rotational maceration was employed in 30% of cases, balloon venoplasty in 38%, and stent placement in 15%. Mean device utilization time was 8.0 minutes, with an average of 2.4 device passes per patient. Mean EBL was 320 mL (range 50-750 mL). The overall complication rate was 2.4% (n=5), consisting exclusively of minor access-site hematomas not attributed to the device. No serious adverse events (SAEs) were device-attributable within the 200-patient cohort. Procedures were predominantly classified as peripheral venous interventions (70%), with the remaining 30% encompassing alternative indications (e.g., in-stent restenosis, transjugular intrahepatic portosystemic shunt revisions). CONCLUSIONS: In this cohort of 200 patients, the CLEANER Vac system demonstrated high procedural efficacy (88.0% mean clot clearance, 76% achieving ≥90% resolution) and a favorable overall safety profile. The findings support the potential role of this system in enabling rapid, single-session VTE treatment with constrained hemorrhagic liability and morbidity compared to CDT. Prospective, longitudinal studies are warranted to evaluate long-term outcomes and delineate optimal patient stratification.