Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06051032

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

Led by Instituto de Investigacion Sanitaria La Fe · Updated on 2025-01-28

60

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

Sponsors

I

Instituto de Investigacion Sanitaria La Fe

Lead Sponsor

H

Hospital Universitario Doctor Peset

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with acute thrombosis (< 10 days) of native or prosthetic AVF.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital La Fe

Valencia, Valencia, Spain, 46026

Actively Recruiting

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Research Team

J

José Martínez Rodrigo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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