Clinical trial NCT06051032: Compative Study of PE in Thrombosed AVF After Balloon Thrombectomy Vs. Thromboaspiration.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism and Thrombosis
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Doctor Peset
First posted: 2023-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients diagnosed with arteriovenous fistula (AVF) thrombosis and eligible for endovascular treatment, based on predefined inclusion and exclusion criteria, will be enrolled in this study. They will be randomly assigned to receive either balloon thrombectomy or thromboaspiration systems.
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Known pulmonary hypertension.
* Severe pulmonary disease.
* Low cardiopulmonary reserve.
* Recent creation of vascular access.
* Known right left shunt.
* Access infection.
* Allergy to iodinated contrast.
* Patients under 18 years old.

Primary outcomes:
measure: Incidence of PTE after thrombectomy of native and prosthetic AVFs.
timeFrame: The presence of PTE will be evaluated within 24 hours after treatment.
measure: PTE resolution rate 1 month after thrombectomy of native and prosthetic AVFs.
timeFrame: The resolution of PTE will be evaluated 1-month after the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital La Fe
state: Comunidad Valenciana
Study officials:
affiliation: Hospital Universitario La Fe
name: José Martínez Rodrigo
role: PRINCIPAL_INVESTIGATOR
References: