Comparing two methods for treating blood clots in arteriovenous fistulas
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Investigacion Sanitaria La Fe Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT06051032 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with acute thrombosis of native or prosthetic AVF occurring within the last 10 days.
Not a fit: Patients with known pulmonary hypertension, severe pulmonary disease, or other significant comorbidities may not benefit from this study.
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 performed: Other studies have explored similar endovascular techniques, but this specific comparison of balloon thrombectomy versus thromboaspiration in AVF thrombosis is relatively novel.
Eligibility criteria
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 this trial is running
Valencia, Valencia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.