Abdominal Aortic Aneurysm Without RuptureEVAR-markersNCT06866769
Efficacy of Biomarkers and CEUS Versus CTA in AAA Follow-up Post-EVAR
An observational study of Abdominal Aortic Aneurysm Without Rupture, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm Without Rupture
- What is being tested?
- CTA
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jul 2024to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- patients with inflammatory abdominal aortic aneurysms or ruptured aneurysm.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital La Fe
Valencia, Valencia, 46026
Juan Manuel Sanchís García, +34961245655, sanchis_juagar@gva.es
About this study
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)
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.
Read the detailed description
Background/Rationale:
Patients with AAA who have undergone EVAR of the abdominal aortic aneurysm require indefinite follow-up since a 4-year complication rate after EVAR of up to 40% has been described in some series.
In some patients a decrease in the diameters of the residual aneurysm sac after EVAR has been described, which is known as remodeling.
CTA is the gold standard imaging technique for the follow-up of these patients, although it has the disadvantage of using ionizing radiation and iodinated contrasts that are nephrotoxic and can produce hypersensitivity reactions. Furthermore, there is no consensus on which protocol is the most suitable (one phase, two phases or three phases). Currently, in our hospital, three-phase CTA is being performed, as well as CTA with the Split Bolus technique, which allows the acquisition of images in arterial and venous phases in a single acquisition, thus reducing radiation doses; a correlation between both techniques of 85.7-100% and a decrease in radiation doses of between 30-78% has been described.
An alternative to CTA is CEUS that presents a sensitivity of 90.5% (22-100%) and a specificity of 90.65% (71-100%) for the detection of endoleaks. It is a technique that does not use ionizing radiation; furthermore, ultrasound contrasts are not nephrotoxic and hypersensitivity reactions to them are exceptional. In addition, there are publications concerning the determination of biomarkers in the follow-up of patients with AAA both before and after treatment with EVAR.
Hypothesis:
Performing CEUS together with biomarker determination in patients with AAA treated by EVAR would allow reducing the number of CTA to these patients; and, therefore, radiation doses and the use of iodinated contrasts that may cause nephrotoxicity, as well as hypersensitivity reactions.
Primary objectives:
- - To determine whether the combination of biomarker levels together with CEUS in the follow-up of treated AAA patients is as effective as performing CTA to detect endoleaks.
- - To validate the usefulness of CEUS together with biomarker determination in the follow-up of these patients.
Secondary Objectives:
1.- To determine the cost-effectiveness of biomarkers in the follow-up of these patients.
To establish a protocol for the follow-up of patients with AAA treated with EVAR, including biomarkers and CEUS.
3.-To reduce radiation doses in the follow-up of patients with AAA treated with EVAR.
Methodology:
Prospective observational study. Biomarker levels will be determined before (within 30 days prior to the procedure) and after stent implantation (24-48 h, 1 month, 3 months, 6 months and 1 year) together with contrast echography. In addition, a control CTA will be performed to validate concordance. These biomarkers will be analyzed comparing the values obtained in patients with endoleaks versus patients without endoleaks, as well as in those with aneurysm remodeling.
- Being tested
- CTA
- Keywords
- Abdominal Aortic Aneurysm (AAA), Endovascular Aneurysm Repair (EVAR), Contrast-enhanced ultrasound (CEUS), Computed tomography angiography (CTA), Biomarkers.
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTADiagnostic test
Also called Ultrasound image enhancement
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.).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: CTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Objective: To evaluate the cost-effectiveness of biomarker determination in the follow-up of AAA patients treated with EVAR, using a Health Economic Evaluation framework.
- Units of Measure: Cost of biomarker tests (in euros).
- Analysis Method: Cost-Effectiveness Analysis (CEA) and Cost-Minimization Analysis (CMA).
Comments: The cost-effectiveness analysis will compare the costs of biomarker measurements to clinical outcomes such as detection and management of complications.
Measured: 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
Objective: To evaluate the cost-effectiveness of imaging techniques (CEUS and CTA) for follow-up of AAA patients treated with EVAR.
- Units of Measure: Cost per imaging session (in euros).
- Analysis Method: Cost-Effectiveness Analysis (CEA) and Cost-Minimization Analysis (CMA).
Comments: The cost-effectiveness of CEUS and CTA will be assessed in relation to clinical outcomes, like the detection and management of complications.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start25 Jul 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic Aneurysm Without RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Manuel Sanchís García, Principal investigator, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866769
- Sponsor's protocol ID
- EVAR
- Acronym
- EVAR-markers
- Status last verified
- Mar 2025
- First submitted
- 24 Jan 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06866769
- Acronym / sponsor ID
- EVAR-markers / EVAR
- Keywords
- Abdominal Aortic Aneurysm (AAA), Endovascular Aneurysm Repair (EVAR), Contrast-enhanced ultrasound (CEUS), Computed tomography angiography (CTA), Biomarkers.
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background/Rationale:
Patients with AAA who have undergone EVAR of the abdominal aortic aneurysm require indefinite follow-up since a 4-year complication rate after EVAR of up to 40% has been described in some series.
In some patients a decrease in the diameters of the residual aneurysm sac after EVAR has been described, which is known as remodeling.
CTA is the gold standard imaging technique for the follow-up of these patients, although it has the disadvantage of using ionizing radiation and iodinated contrasts that are nephrotoxic and can produce hypersensitivity reactions. Furthermore, there is no consensus on which protocol is the most suitable (one phase, two phases or three phases). Currently, in our hospital, three-phase CTA is being performed, as well as CTA with the Split Bolus technique, which allows the acquisition of images in arterial and venous phases in a single acquisition, thus reducing radiation doses; a correlation between both techniques of 85.7-100% and a decrease in radiation doses of between 30-78% has been described.
An alternative to CTA is CEUS that presents a sensitivity of 90.5% (22-100%) and a specificity of 90.65% (71-100%) for the detection of endoleaks. It is a technique that does not use ionizing radiation; furthermore, ultrasound contrasts are not nephrotoxic and hypersensitivity reactions to them are exceptional. In addition, there are publications concerning the determination of biomarkers in the follow-up of patients with AAA both before and after treatment with EVAR.
Hypothesis:
Performing CEUS together with biomarker determination in patients with AAA treated by EVAR would allow reducing the number of CTA to these patients; and, therefore, radiation doses and the use of iodinated contrasts that may cause nephrotoxicity, as well as hypersensitivity reactions.
Primary objectives:
- - To determine whether the combination of biomarker levels together with CEUS in the follow-up of treated AAA patients is as effective as performing CTA to detect endoleaks.
- - To validate the usefulness of CEUS together with biomarker determination in the follow-up of these patients.
Secondary Objectives:
1.- To determine the cost-effectiveness of biomarkers in the follow-up of these patients.
To establish a protocol for the follow-up of patients with AAA treated with EVAR, including biomarkers and CEUS.
3.-To reduce radiation doses in the follow-up of patients with AAA treated with EVAR.
Methodology:
Prospective observational study. Biomarker levels will be determined before (within 30 days prior to the procedure) and after stent implantation (24-48 h, 1 month, 3 months, 6 months and 1 year) together with contrast echography. In addition, a control CTA will be performed to validate concordance. These biomarkers will be analyzed comparing the values obtained in patients with endoleaks versus patients without endoleaks, as well as in those with aneurysm remodeling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Diagnostic Test: CTAInclusion 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- patients with inflammatory abdominal aortic aneurysms or ruptured aneurysm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTAAlso: Ultrasound image enhancementThe 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.). | Diagnostic test | Study cohort |
Primary outcome
Biomarkers Levels for Endoleak Detection Post-EVAR Treatment
Time frame: 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).
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 Levels for Thrombosis Detection Post-EVAR Treatment
Time frame: 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).
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 Levels for Infection Detection Post-EVAR Treatment
Time frame: 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).
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.
Biomarker Levels for Prosthesis-Related Complication Detection Post-EVAR Treatment
Time frame: 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).
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.
CEUS (Contrast-Enhanced Ultrasound) for Endoleak Detection Post-EVAR treatment
Time frame: 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.
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
Validation of CEUS for Endoleak and Complication Detection Post-EVAR treatment
Time frame: 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.
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.
Validation of Biomarkers for Endoleaks Detection Post EVAR
Time frame: 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.
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
Validation of Biomarkers for Thrombosis Detection Post-EVAR treatment
Time frame: 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.
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.
Validation of Biomarkers for Infection Detection Post-EVAR treatment
Time frame: 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.
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.
Validation of Biomarkers for Prosthesis-Related Complication Detection Post-EVAR Treatment
Time frame: 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.
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.
2 secondary outcomes
Cost-Effectiveness of Biomarker Measurements in AAA Follow-Up Post-EVAR treatment
Time frame: 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
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan Manuel Sanchís García principal investigator
Hospital Universitario La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm Without Rupture, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Manuel Sanchís García (+34 961245655, sanchis_juagar@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers Levels for Endoleak Detection Post-EVAR Treatment (time frame: 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).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.