Interventions for thrombosed haemodialysis arteriovenous fistulas and grafts.
Andre V Fonseca, Marcos G Toledo Barros, Jose Cc Baptista-Silva...
https://pubmed.ncbi.nlm.nih.gov/38353936Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06051032
Prospective Randomized Comparative Study on Pulmonary Embolism After Endovascular Treatment of Thrombosed Dialysis Arteriovenous Fistulas Using Balloon Thrombectomy or Thromboaspiration
Led by Instituto de Investigacion Sanitaria La Fe · Updated on 2025-01-28
60
Participants Needed
1
Research Sites
N/A
Total Duration
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Sponsors
I
Instituto de Investigacion Sanitaria La Fe
Lead Sponsor
H
Hospital Universitario Doctor Peset
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare the occurrence of pulmonary thromboembolism (PTE) in patients with acute thrombosis of native or prosthetic arteriovenous fistulas (AVF) undergoing endovascular treatment. The study evaluates two treatments: balloon thrombectomy and thromboaspiration systems. It also examines the primary patency rate, clinical success rate, and costs associated with each thrombectomy technique. Participants will receive either balloon thrombectomy, where a catheter with an inflatable balloon removes the clot by pressure, or a thromboaspiration system, which uses suction to gently remove the clot. Both procedures are guided by imaging techniques to ensure accurate placement. The study is randomized and double-blind, with patients assigned to one of these two treatment groups. During the study, the presence of PTE will be assessed within 24 hours after treatment using AngioCT, and the resolution of PTE will be evaluated one month later. Researchers will monitor clinical success, patency rates of the fistulas, and treatment costs. Participants will be followed closely to measure these outcomes and safety over the study period.
CONDITIONS
Brief Title
Compative Study of PE in Thrombosed AVF After Balloon Thrombectomy Vs. Thromboaspiration.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with acute thrombosis (less than 10 days) of native or prosthetic arteriovenous fistulas
- Patients 18 years of age or older
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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1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Procedure day with assessments within 24 hours after treatment
Participants receive endovascular treatment for thrombosed arteriovenous fistulas using either balloon thrombectomy or thromboaspiration system.
1 procedure day and 1 post-treatment visit within 24 hours (in-person)
Follow-up
Duration - 1 month
Participants are monitored for pulmonary thromboembolism (PTE) resolution after the treatment.
1 follow-up visit at 1 month (in-person)
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
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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