Post-Implantation Syndrome and Laboratory Markers Following EVAR and TEVAR

NCT07014839 | Completed

• 1 other identifier: UA_ES_01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this observational study is to investigate the relationship between postimplantation syndrome (PIS) and laboratory inflammatory parameters following endovascular aortic repair (EVAR/TEVAR). PIS is a systemic inflammatory response that may occur after EVAR or TEVAR and lacks a standardized clinical definition. This study seeks to determine whether specific laboratory biomarkers-particularly white blood cell count, C-reactive protein (CRP), interleukin levels, and neutrophil-to-lymphocyte ratio (NLR)-can serve as reliable indicators for the diagnosis and assessment of PIS.

Conditions

Postimplantation Syndrome; Endovascular Abdominal Aortic Aneurysm Repair (EVAR); Thoracic Endovascular Aortic Repair

Keywords

Postimplantation Syndrome; Endovascular repair of aortic aneurysms

Outcome Measures

Primary Outcomes (1)

• Evaluation of Postimplantation Syndrome (PIS) Incidence

  PIS is defined as the presence of fever (\>38°C) without an identifiable source of infection, accompanied by leukocytosis (white blood cell count \>12,000/mm³) and/or elevated C-reactive protein (CRP \>7 mg/L). The incidence rate of PIS will be calculated based on the number of patients meeting these diagnostic criteria following EVAR or TEVAR procedures. Unit of Measure: Percentage of participants with PIS (%)

  0-8 days

Secondary Outcomes (5)

• C-reactive Protein (CRP) Level

  within first 72 hours postoperatively

• White Blood Cell (WBC) Count

  within first 72 hours postoperatively

• Interleukin-6 (IL-6) Level

  within first 72 hours postoperatively

• Neutrophil-to-Lymphocyte Ratio (NLR)

  within first 72 hours postoperatively

• Procalcitonin (PCT) Level

  within first 72 hours postoperatively

Study Arms (1)

Post-Implantation Syndrome: Lab Trends after EVAR/TEVAR

This cohort includes patients who underwent endovascular aneurysm repair (EVAR) or thoracic endovascular aortic repair (TEVAR). The study investigates the occurrence of post-implantation syndrome (PIS) and its association with early postoperative laboratory markers, including interleukin-6 (IL-6), neutrophil-to-lymphocyte ratio (NLR), leukocyte count, C-reactive protein (CRP), and procalcitonin levels. No additional pharmacologic or procedural interventions were applied beyond standard perioperative care.

Procedure: Endovascular Aortic Intervention

Interventions

Endovascular Aortic Intervention PROCEDURE

This intervention involves EVAR or TEVAR for the treatment of abdominal or thoracic aortic aneurysms, respectively. The procedures were performed using commercially available stent-grafts via a transfemoral approach under standard perioperative protocols. The study specifically focuses on the systemic inflammatory response following these interventions, with close monitoring of laboratory parameters including IL-6, neutrophil-to-lymphocyte ratio (NLR), CRP, leukocyte count, and procalcitonin during the early postoperative period. No adjunctive anti-inflammatory or immunomodulatory therapies were administered.

Post-Implantation Syndrome: Lab Trends after EVAR/TEVAR

Eligibility Criteria

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

Study Population

The study population consists of adult patients (≥18 years) who underwent elective endovascular aneurysm repair (EVAR) or thoracic endovascular aortic repair (TEVAR) for abdominal or thoracic aortic aneurysms at a single tertiary care center. All participants had available pre- and postoperative laboratory data necessary for the evaluation of post-implantation syndrome and inflammatory biomarkers.

You may qualify if:

• Patients aged ≥18 years
• Undergoing elective EVAR or TEVAR for abdominal or thoracic aortic aneurysm
• Ability to provide informed consent
• Availability of baseline and follow-up laboratory data (including IL-6, NLR, CRP, leukocyte count, procalcitonin, etc.)

You may not qualify if:

• Evidence of active infection at the time of procedure
• Known autoimmune or inflammatory disease (e.g., rheumatoid arthritis, lupus)
• Current use of immunosuppressive or anti-inflammatory therapy
• Malignancy under active treatment
• End-stage renal or hepatic failure
• Emergency or ruptured aneurysm repair
• Incomplete postoperative laboratory data

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (3)

Atatürk University

Erzurum, 25025, Turkey (Türkiye)

Location

Atatürk University

Erzurum, 25100, Turkey (Türkiye)

Location

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (1)

• D'Oria M, Manoranjithan S, Scoville C, Vogel TR, Cheung S, Calvagna C, Lepidi S, Bath J. Systematic review of risk factors and outcomes of post-implantation syndrome following endovascular aortic repair. J Vasc Surg. 2024 May;79(5):1240-1250.e4. doi: 10.1016/j.jvs.2023.12.029. Epub 2023 Dec 18.

  PMID: 38122858 RESULT

Study Officials

• umit arslan

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 11, 2025
• Study Start: January 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: April 15, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)