Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Comparing two methods for treating blood clots in arteriovenous fistulas

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.

Run by Instituto de Investigacion Sanitaria La Fe · NCT06051032 · Data updated 2026-11-12

This study is testing whether using balloon thrombectomy or thromboaspiration is better for treating blood clots in arteriovenous fistulas and if it affects the risk of lung problems and treatment success.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorInstituto de Investigacion Sanitaria La Fe
Academic / other
Locations1 site (Valencia, Valencia)
StatusRecruiting
StartedJuly 21, 2023
Main results expectedMarch 2025
Study endsMarch 2025
Registry record updatedJanuary 28, 2025
Trial IDNCT06051032 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients with acute thrombosis of native or prosthetic AVF occurring within the last 10 days.

Probably not a fit

Patients with known pulmonary hypertension, severe pulmonary disease, or other significant comorbidities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicentric clinical trial aims to compare the incidence of pulmonary thromboembolism (PTE) in patients undergoing endovascular treatment for acute thrombosis in native and prosthetic arteriovenous fistulas (AVF) using either balloon thrombectomy or thromboaspiration systems. The study will assess the differences in PTE incidence, primary patency rates, clinical success rates, and associated costs of the two treatment methods. Participants will be randomly assigned to receive one of the two interventions, and their outcomes will be monitored through AngioCT imaging. The trial seeks to provide insights into the most effective treatment approach for this condition.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with thrombosed arteriovenous fistulas, potentially reducing the incidence of pulmonary embolism.

How similar studies have gone: Other studies have explored similar endovascular techniques, but this specific comparison of balloon thrombectomy versus thromboaspiration in AVF thrombosis is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Hospital La Fe
    Valencia, Valencia, Spain
    Recruiting

Study contacts

  • Principal investigator: José Martínez Rodrigo — Hospital Universitario La Fe
  • Study coordinator: José Martínez Rodrigo
  • Email: martinez_jjo@gva.es
  • Phone: +34 961244369

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.