Analysis of real-world multicenter experience with the large-bore CLEANER-Vac Thrombectomy System: An analysis of 200 patients.

Abstract

Background: Venous thromboembolism (VTE), encompassing deep vein thrombosis and pulmonary embolism, represents a significant clinical entity associated 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 suboptimally 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 end points included thrombus clearance efficacy, segmented venous involvement, estimated blood loss, and intraprocedural adverse event incidence.

Results: The study cohort had a mean age of 64.5 (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 preprocedure clot burden was 88.0%, which decreased to 10.5% postprocedure, culminating in a mean thrombus clearance of 88.0%. Overall, 76.0% of patients (n = 152) achieved ≥90% clot resolution. Adjunctive rotational maceration was used 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 estimated blood loss was 320 (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 were device-attributable within the 200-patient cohort. Procedures were predominantly classified as peripheral venous interventions (70%), with the remaining 30% encompassing alternative indications (eg, in-stent restenosis and 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 with catheter-directed thrombolysis. Prospective, longitudinal studies are warranted to evaluate long-term outcomes and delineate optimal patient stratification.