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

NCT06866769 | Recruiting DMC FDA Device

• 1 other identifier: EVAR
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Aortic Aneurysm Without Rupture

Keywords

Abdominal Aortic Aneurysm (AAA); Endovascular Aneurysm Repair (EVAR); Contrast-enhanced ultrasound (CEUS); Computed tomography angiography (CTA); Biomarkers.

Outcome Measures

Primary Outcomes (10)

• Biomarkers Levels for Endoleak Detection Post-EVAR Treatment

  To determine if biomarker levels can detect endoleaks as a complication in patients treated for AAA, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Endoleak Biomarkers from baseline to 1 year. Biomarkers and Units of Measure: * Extracellular Matrix Remodeling Markers: Matrix Metalloproteinase-9 (MMP-9) (ng/mL) * Renal Function Markers: Cystatin C (mg/L) * Coagulation Markers: von Willebrand Factor (%), Factor VIII (IU/dL) Analysis: Each biomarker will be grouped into clinically relevant categories and analyzed as an independent measure within its respective category to assess its correlation with endoleak occurrence.

  Biomarkers will be evaluated before (within 30 days prior to the procedure) and after implantation of the endoprosthesis (24-48 hours, 1 month, 3 months, 6 months, and 1 year).

• Biomarkers Levels for Thrombosis Detection Post-EVAR Treatment

  To determine if biomarker levels detect thrombosis in AAA patients, changes will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Thrombosis Biomarkers from baseline to 1 year. Biomarkers and Units of Measure: * Coagulation Markers: Prothrombin Time (PT) (seconds), Activated Partial Thromboplastin Time (aPTT) (seconds), Derived Fibrinogen (mg/dL), Factor XIII (%) * Platelet Function Markers: PFA-100 COL/ADP (seconds), PFA-100 COL/EPI (seconds) * Anticoagulation Markers: Protein C (%), Protein S (%), Antithrombin (%) * Thrombophilia Markers: Lupus Anticoagulant (Presence/Absence), Activated Protein C Resistance ((+/-)), Prothrombin G20210A Mutation ((+/-)), Factor V Leiden Mutation (G1691A) ((+/-)) Analysis: Each biomarker will be grouped into clinically relevant categories and analyzed as an independent measure within its respective category to track changes and assess their correlation with thrombosis.

  Biomarkers will be evaluated before (within 30 days prior to the procedure) and after implantation of the endoprosthesis (24-48 hours, 1 month, 3 months, 6 months, and 1 year).

• Biomarkers Levels for Infection Detection Post-EVAR Treatment

  To determine if biomarker levels can detect infection as a complication in patients treated for AAA, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Infection Biomarkers from baseline to 1 year. Biomarkers and Units of Measure: \- Inflammatory Markers: C-Reactive Protein (CRP) (mg/L); Procalcitonin (ng/mL); IL-6 (pg/mL); IL-8 (pg/mL); TNF-α (pg/mL); Serum Calprotectin (µg/mL) Analysis: Each biomarker will be grouped as an inflammatory marker and analyzed as an independent measure to track changes and assess its correlation with infection.

  Biomarkers will be evaluated before (within 30 days prior to the procedure) and after implantation of the endoprosthesis (24-48 hours, 1 month, 3 months, 6 months, and 1 year).

• Biomarker Levels for Prosthesis-Related Complication Detection Post-EVAR Treatment

  To determine whether biomarker levels can detect complications such as displacement, dislocation, and plication of the prosthesis in patients treated for AAA, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Biomarkers Related to Prosthesis Issues from baseline to 1 year. Biomarkers and Units of Measure: * Lipid Metabolism Markers: Apolipoprotein A1 (ApoA1) (mg/dL), Apolipoprotein B (ApoB) (mg/dL) * Hematological Markers: Reticulocytes (10³/mL) * Coagulation Markers: Quick Index (%) * Autoimmune Markers: Anticardiolipin Antibodies (IgG/IgM) (GPL/MPL units) Analysis: Each biomarker will be grouped into clinically relevant categories and treated as an independent measure within its respective category.

  Biomarkers will be evaluated before (within 30 days prior to the procedure) and after implantation of the endoprosthesis (24-48 hours, 1 month, 3 months, 6 months, and 1 year).

• CEUS (Contrast-Enhanced Ultrasound) for Endoleak Detection Post-EVAR treatment

  Objective: To determine if CEUS can detect endoleaks, thrombosis, infection, and complications related to protesis placement (displacement/dislocation of the prosthesis, plication of the prosthesis) in patients treated for AAA. • Units of Measure: Presence/absence of endoleaks, thrombosis, infection, displacement/dislocation of the prosthesis, plication of the prosthesis Comments: The presence or absence of endoleaks and other complications will be assessed, along with severity when applicable

  CEUS will be performed at baseline (within 30 days before the procedure) and after implantation of the endoprosthesis: 24-48 hours, 1 month, 3 months, 6 months, and 1 year.

• Validation of CEUS for Endoleak and Complication Detection Post-EVAR treatment

  Objective: To validate the use of Contrast-Enhanced Ultrasound (CEUS) for detecting endoleaks, thrombosis, infection, and complications related to protesis placement (displacement/dislocation of the prosthesis, plication of the prosthesis) in patients treated for AAA, compared to angio-CT (gold standard). * Units of Measure: Presence/absence of endoleaks, thrombosis, infection, displacement/dislocation of the prosthesis, plication of the prosthesis * Comparison Standard: Angio-CT (gold standard) Comments: The presence or absence of endoleaks and other complications will be assessed, along with severity when applicable. CEUS results will be compared to the angio-CT results for validation.

  CEUS will be performed at baseline (within 30 days before the procedure) and after implantation of the endoprosthesis: 24-48 hours, 1 month, 3 months, 6 months, and 1 year.

• Validation of Biomarkers for Endoleaks Detection Post EVAR

  To validate biomarkers for detecting endoleaks as a post-EVAR complication, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Endoleak Biomarkers from baseline to 1 year. Biomarkers and Units of Measure: * Extracellular Matrix Remodeling Markers: Matrix Metalloproteinase-9 (MMP-9) (ng/mL) * Renal Function Markers: Cystatin C (mg/L) * Coagulation Markers: von Willebrand Factor (%), Factor VIII (IU/dL) Analysis: Each biomarker will be grouped into clinically relevant categories and analyzed as an independent measure within its respective category to assess its correlation with endoleak occurrence

  Biomarkers will be assessed at baseline (within 30 days prior to the procedure) and after implantation of the endoprosthesis: 24-48 hours, 1 month, 3 months, 6 months, and 1 year.

• Validation of Biomarkers for Thrombosis Detection Post-EVAR treatment

  To validate biomarkers for detecting thrombosis as a post-EVAR complication, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Thrombosis Biomarkers from baseline to 1 year. Biomarkers and Units of Measure: * Coagulation Markers: Prothrombin Time (PT) (seconds), Activated Partial Thromboplastin Time (aPTT) (seconds), Derived Fibrinogen (mg/dL), Factor XIII (%) * Platelet Function Markers: PFA-100 COL/ADP (seconds), PFA-100 COL/EPI (seconds) * Anticoagulation Markers: Protein C (%), Protein S (%), Antithrombin (%) * Thrombophilia Markers: Lupus Anticoagulant (Presence/Absence), Activated Protein C Resistance ((+/-)), Prothrombin G20210A Mutation ((+/-)), Factor V Leiden Mutation (G1691A) ((+/-)) Analysis: Each biomarker will be grouped into clinically relevant categories and analyzed as an independent measure within its respective category to track changes and assess their correlation with thrombosis.

  Biomarkers will be assessed at baseline (within 30 days prior to the procedure) and after implantation of the endoprosthesis: 24-48 hours, 1 month, 3 months, 6 months, and 1 year.

• Validation of Biomarkers for Infection Detection Post-EVAR treatment

  To validate biomarkers for detecting infection as a post-EVAR complication, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Infection Biomarkers from baseline to 1 year. Biomarkers and Units of Measure: \- Inflammatory Markers: C-Reactive Protein (CRP) (mg/L); Procalcitonin (ng/mL); IL-6 (pg/mL); IL-8 (pg/mL); TNF-α (pg/mL); Serum Calprotectin (µg/mL) Analysis: Each biomarker will be grouped as an inflammatory marker and analyzed as an independent measure to track changes and assess its correlation with infection.

  Biomarkers will be assessed at baseline (within 30 days prior to the procedure) and after implantation of the endoprosthesis: 24-48 hours, 1 month, 3 months, 6 months, and 1 year.

• Validation of Biomarkers for Prosthesis-Related Complication Detection Post-EVAR Treatment

  To validate biomarkers for detecting complications such as displacement, dislocation, and plication of the prosthesis, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Biomarkers Related to Prosthesis Issues from baseline to 1 year. Biomarkers and Units of Measure: * Lipid Metabolism Markers: Apolipoprotein A1 (ApoA1) (mg/dL), Apolipoprotein B (ApoB) (mg/dL) * Hematological Markers: Reticulocytes (10³/mL) * Coagulation Markers: Quick Index (%) * Autoimmune Markers: Anticardiolipin Antibodies (IgG/IgM) (GPL/MPL units) Analysis: Each biomarker will be grouped into clinically relevant categories and analyzed as an independent measure within its respective category.

  Biomarkers will be assessed at baseline (within 30 days prior to the procedure) and after implantation of the endoprosthesis: 24-48 hours, 1 month, 3 months, 6 months, and 1 year.

Secondary Outcomes (2)

• Cost-Effectiveness of Biomarker Measurements in AAA Follow-Up Post-EVAR treatment

  Biomarkers will be evaluated before (within 30 days prior to the procedure) and after implantation of the endoprosthesis (24-48 hours, 1 month, 3 months, 6 months, and 1 year).

• Cost-Effectiveness of Imaging (CEUS and CTA) in AAA Follow-Up Post-EVAR treatment

  Imaging techniques (CEUS and CTA) will be performed at the same time points as biomarker assessments (within 30 days before the procedure, and after implantation: 24-48 hours, 1 month, 3 months, 6 months, and 1 year)

Study Arms (1)

Study cohort

Inclusion Criteria: * patients with AAA under follow-up who are going to be treated with EVAR. * signed informed consent to perform CTA, CEUS and for the determination of biomarkers. Exclusion Criteria: * patients with inflammatory abdominal aortic aneurysms or ruptured aneurysm.

Diagnostic Test: CTA

Interventions

CTA DIAGNOSTIC_TEST

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.).

Also known as: Ultrasound image enhancement

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AAA treated with EVAR will undergo a clinical evaluation prior to the procedure, assessing inclusion and exclusion criteria. A determination of biomarkers will be carried out to determine their values before the procedure, which will be carried out within 30 days of said assessment. Patients who meet the inclusion criteria will be studied prospectively to assess the effectiveness of biomarker levels along with CEUS to detect endoleaks.

You may qualify if:

• patients with AAA under follow-up who are going to be treated with EVAR.
• signed informed consent to perform CTA, CEUS and for the determination of biomarkers.

You may not qualify if:

• patients with inflammatory abdominal aortic aneurysms or ruptured aneurysm.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Hospital La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Juan Manuel Sanchís García

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Manuel Sanchís García

CONTACT

+34 961245655; sanchis_juagar@gva.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: March 10, 2025
• Study Start: July 25, 2024
• Primary Completion: July 30, 2025
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)