Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06866769

Efficacy of Biomarkers and CEUS Versus CTA in AAA Follow-up Post-EVAR

Sponsor: Instituto de Investigacion Sanitaria La Fe

View on ClinicalTrials.gov

Summary

This prospective observational study evaluates the efficacy of contrast-enhanced ultrasound and biomarker determination in the follow-up of patients with abdominal aortic aneurysm (AAA) treated with Endovascular Aneurysm Repair (EVAR). Currently, computed tomography angiography (CTA) is the standard for follow-up, although it has disadvantages such as radiation exposure and the use of iodinated contrasts. Contrast-enhanced ultrasound (CEUS), free of radiation and nephrotoxicity, and biomarkers could reduce the need for CTA minimizing the associated risks. Biomarkers will be measured before and after EVAR and CEUS will be performed at various time points and compared with CTA results to validate concordance and effectiveness in detecting endoleaks and aneurysm remodeling. The objectives include determining the efficacy of these combined methods and establishing a follow-up protocol that reduces exposure to radiation and iodinated contrast agents.

Official title: Comparación De La Eficacia Entre Biomarcadores Y Ecografía Con Contraste Frente a Angio-TC En El Seguimiento De Aneurismas De Aorta Abdominal (AAA) Tras Reparación Endovascular (EVAR)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2024-07-25

Completion Date

2028-04-30

Last Updated

2025-03-10

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

CTA

The levels of biomarkers are determined before (within 30 days prior to the procedure) and after the implantation of the stent (24-48 hours, 1 month, 3 months, 6 months, and at 1 year), along with the performance of a contrast-enhanced ultrasound. Additionally, a follow-up CT angiography is performed to validate the concordance, that is, to assess if there are changes in the biomarker values determined one month after the implantation of the stent compared to the baseline values that may suggest the presence of complications (endoleaks, infection, thrombosis, etc.).

Locations (1)

Hospital La Fe

Valencia, Valencia, Spain