Prospective Randomized Comparative Study on the Incidence of Pulmonary Emboembolism (PE) After Endovascular Treatment of Thrombosed Dialysis Arterio Venous Fistulas (AVF): Balloon Thrombectomy Versus Thromboaspiration Systems.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with acute thrombosis (\< 10 days) of native or prosthetic AVF.

Locations
Other Locations
Spain
Hospital La Fe
RECRUITING
Valencia
Contact Information
Primary
José Martínez Rodrigo
martinez_jjo@gva.es
+34 961244369
Time Frame
Start Date: 2023-07-21
Estimated Completion Date: 2025-03
Participants
Target number of participants: 60
Treatments
Experimental: Balloon thrombectomy
Patients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo balloon thrombectomy.
Experimental: Thromboaspiration system
Patients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo the thromboaspiration system.
Sponsors
Collaborators: Hospital Universitario Doctor Peset
Leads: Instituto de Investigacion Sanitaria La Fe

This content was sourced from clinicaltrials.gov

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