Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Patients with acute thrombosis (< 10 days) of native or prosthetic AVF.
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
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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