Real-World Multicenter Experience with the CLEANER VacTM Thrombectomy System: An Analysis of the First 30 Patients
Year: 2025
Type: article
Abstract: : A retrospective, multicenter analysis was conducted across multiple institutions, evaluating patients with acute or subacute symptomatic venous thrombosis who underwent treatment with the CLEANER Vac thrombectomy device. Inclusion criteria included adults aged 18 years or older presenting with venous thrombus confirmed via duplex ultrasonog- raphy, CT venography, or conventional venography. Patients were treated using a standardized protocol, with vascular access achieved via femoral, popliteal, or jugular veins depending on thrombus location. The CLEANER Vac device was advanced to the thrombus site under fluoroscopic guidance, and aspiration thrombectomy was performed. Comple- tion venography was utilized to assess clot clearance, and adjunctive therapies such as angioplasty or catheter-directed thrombolysis were administered at physician discretion when residual thrombus remained. Data collection included de- mographic details, pre- and post-procedure clot burden, thrombus clearance rates, adjunctive therapy use, and procedural complications. Results: The study cohort comprised 30 patients with a mean age of 58.8 years (range: 28–88 years). The gender distribution was 50.0% male (n=15), 50.0% female (n=15%). On average, 2.4 venous segments were treated per patient. The mean pre-treatment clot burden was 95.4%, which was reduced to an average post-treatment clot burden of 6.0%, resulting in an average clot clearance rate of 93.1%. A total of 24 patients (82.8%) achieved ≥90% clot clearance, demonstrating a high procedural success rate. In the subset of patients requiring adjunctive therapy, rotational maceration was the most commonly used adjunct to aspiration thrombectomy. Balloon angioplasty was the most commonly utilized technique to optimize venous patency post-thrombectomy. Procedural safety was favorable, with no major complications, including symptomatic pulmonary embolism, vessel perforation, or severe bleeding requiring transfusion. No minor complications such as access-site hematomas were observed in this first thirty patient cohort, Conclusions: This real-world, multicenter study highlights the efficacy and safety of the CLEANER Vac Thrombectomy System in the treatment of symptomatic venous thrombosis. The system demonstrated high rates of successful thrombus clearance with minimal procedural complications, supporting its role as an effective mechanical thrombectomy option for the management of peripheral venous thrombosis. The ability to achieve substantial clot burden reduction with a controlled aspiration mechanism provides an advantage over existing mechanical thrombectomy platforms. While these initial findings are promising, further prospective studies with larger patient cohorts and long-term follow-up are warranted to validate the sustained efficacy and durability of treatment outcomes.
Authors: Stibbs, Peter, Martin, Giles, Worth, David
Institution: University of Nottingham
Language: English
Subfield: Internal Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6893147040
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