Clinical Trial

Compative Study of PE in Thrombosed AVF After Balloon Thrombectomy Vs. Thromboaspiration.

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Record status
This record was last updated January 28, 2025 (before its estimated March 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this multicentric clinical trial is to compare the incidence of pulmonary thromboembolism (PTE), assessed through AngioCT, in the endovascular treatment of acute thrombosis in native and prosthetic arteriovenous fistulas (AVF). The main questions it aims to answer are: * What is the difference in the incidence of pulmonary thromboembolism (PTE) assessed by AngioCT in endovascular treatment of acute thrombosis of native and prosthetic arteriovenous fistulas using balloon thrombectomy versus thromboaspiration systems? * What is the primary patency rate of arteriovenous fistulas treated with balloon thrombectomy versus thromboaspiration systems? * What is the clinical success rate in the treatment of arteriovenous fistulas using balloon thrombectomy compared to thromboaspiration systems? * What are the costs associated with the different thrombectomy techniques in the treatment of arteriovenous fistulas? Participants will be underwent to balloon thrombectomy versus thromboaspiration systems. Researchers will compare the patients treated with balloon thrombectomy and thromboaspiration systems to see if the incidence of PE is comparable and to evaluate the primary and secondary patency rates of both thrombectomy techniques, the clinical technical success rate, and the costs associated with each technique.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-09-18.
Trial Details
NCT Number NCT06051032
Lead Sponsor Instituto de Investigacion Sanitaria La Fe
Collaborators: Hospital Universitario Doctor Peset
Conditions Pulmonary Embolism and Thrombosis
Enrollment 60 participants
Start Date 2023-07-21
Primary Completion 2025-03 (estimated)
Study Completion 2025-03 (estimated)
Updated on ClinicalTrials.gov 2025-01-28