NCT06051032 Compative Study of PE in Thrombosed AVF After Balloon Thrombectomy Vs. Thromboaspiration.
| NCT ID | NCT06051032 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigacion Sanitaria La Fe |
| Condition | Pulmonary Embolism and Thrombosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-07-21 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-07-21 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
José Martínez Rodrigo
PRINCIPAL INVESTIGATOR
Hospital Universitario La Fe
Frequently Asked Questions
Who can join the NCT06051032 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Embolism and Thrombosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06051032 currently recruiting?
Yes, NCT06051032 is actively recruiting participants. Contact the research team at martinez_jjo@gva.es for enrollment information.
Where is the NCT06051032 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT06051032 clinical trial?
NCT06051032 is sponsored by Instituto de Investigacion Sanitaria La Fe. The principal investigator is José Martínez Rodrigo at Hospital Universitario La Fe. The trial plans to enroll 60 participants.