Postimplantation SyndromePIS and EVARNCT07014839
Post-Implantation Syndrome and Laboratory Markers Following EVAR and TEVAR
An observational study of Postimplantation Syndrome and Endovascular Abdominal Aortic Aneurysm Repair (EVAR), run by Ataturk University at 3 sites in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postimplantation Syndrome, Endovascular Abdominal Aortic Aneurysm Repair (EVAR), Thoracic Endovascular Aortic Repair
- What is being tested?
- Endovascular Aortic Intervention
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 15 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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.
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Atatürk University
Erzurum, 25025
Atatürk University
Erzurum, 25100
Ataturk University
Erzurum, 25240
About this study
Official title: Biomarkers Predicting Postimplantation Syndrome After Endovascular Aortic Repair (EVAR) and Thoracic Endovascular Aortic Repair (TEVAR)
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.
Read the detailed description
Endovascular repair of thoracic and abdominal aortic aneurysms (EVAR/TEVAR) has become a preferred alternative to open surgical repair due to its association with reduced perioperative morbidity and mortality. However, a notable proportion of patients undergoing these procedures may develop postimplantation syndrome (PIS), a systemic inflammatory response first described in 1999. Despite its clinical relevance, PIS remains poorly defined, with varying diagnostic criteria across the literature.
PIS is typically characterized by postoperative fever, fatigue, and an increase in inflammatory markers such as white blood cell (WBC) count, C-reactive protein (CRP), and interleukin-6 (IL-6). The neutrophil-to-lymphocyte ratio (NLR), a readily obtainable marker from complete blood count tests, has also gained attention as a reliable indicator of systemic inflammation. In contrast, procalcitonin levels in PIS patients often remain within normal limits, helping differentiate PIS from bacterial infections.
In this prospective observational study, 200 patients undergoing elective EVAR or TEVAR procedures under general anesthesia were included. All procedures were performed via bilateral femoral artery access using open femoral incisions. Patients were followed postoperatively and assessed for the development of PIS based on clinical and laboratory parameters.
Body temperature was measured at regular intervals, and inflammatory markers-including CRP, WBC count, IL-6, NLR, and procalcitonin-were recorded preoperatively and at 24, 48, and 72 hours postoperatively. PIS was defined as the presence of fever (>38°C) in association with elevated CRP and/or leukocytosis, in the absence of any clinical or microbiological evidence of infection.
Preliminary results showed that patients who developed PIS had significantly higher postoperative levels of WBC, CRP, IL-6, and NLR, while procalcitonin levels remained normal, supporting a non-infectious inflammatory etiology. Imaging and laboratory evaluations ruled out alternative sources of infection. No significant differences were observed in operative time or graft type between patients with and without PIS.
All data were collected prospectively and analyzed using the SPSS statistical software. The study aims to clarify the diagnostic criteria of PIS by identifying specific laboratory biomarkers that can reliably differentiate PIS from other postoperative complications, particularly infection. Furthermore, by better understanding the inflammatory response following EVAR/TEVAR, the study may contribute to improved postoperative management strategies.
- Conditions
- Postimplantation Syndrome, Endovascular Abdominal Aortic Aneurysm Repair (EVAR), Thoracic Endovascular Aortic Repair
- Being tested
- Endovascular Aortic Intervention
- Keywords
- Postimplantation Syndrome, Endovascular repair of aortic aneurysms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Aortic InterventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endovascular Aortic Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 0-8 days
Secondary outcomes (5)
C-reactive Protein (CRP) Level
Serum CRP levels will be measured preoperatively and within 72 hours postoperatively. CRP values >7 mg/L will be considered elevated and potentially supportive of PIS diagnosis.
Unit of Measure:
mg/L
Measured: within first 72 hours postoperatively
White Blood Cell (WBC) Count
Total leukocyte count will be assessed preoperatively and within 72 hours postoperatively. Values >12,000/mm³ will be considered elevated.
Unit of Measure:
10³ cells/μL
Measured: within first 72 hours postoperatively
Interleukin-6 (IL-6) Level
Plasma IL-6 concentration will be measured preoperatively and within 72 hours postoperatively. IL-6 levels >7 ng/mL will be considered indicative of systemic inflammation.
Unit of Measure:
ng/mL
Measured: within first 72 hours postoperatively
Neutrophil-to-Lymphocyte Ratio (NLR)
Neutrophil-to-Lymphocyte Ratio (NLR)
Description:
NLR will be calculated from the differential leukocyte count. A value >4 will be used as a cut-off indicating systemic inflammatory response.
Unit of Measure:
Unitless (ratio)
Measured: within first 72 hours postoperatively
Procalcitonin (PCT) Level
Serum procalcitonin levels will be evaluated preoperatively and within 72 hours postoperatively. PCT <1 ng/mL will be considered as non-specific for bacterial infection but still relevant in inflammatory profiling.
Unit of Measure:
ng/mL
Measured: within first 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jan 2018
- Primary completion31 Dec 2024
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postimplantation SyndromeStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ümit arslan, Ataturk University
- Investigators
- umit arslan, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014839
- Sponsor's protocol ID
- UA_ES_01
- Acronym
- PIS and EVAR
- Status last verified
- Jun 2025
- First submitted
- 12 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available due to institutional policies and the potential for overlapping use of the same dataset by other researchers within the institution. However, data may be shared upon reasonable request, provided that appropriate ethical approvals and data-sharing agreements are in place
Publications
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.
PubMed 38122858
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers Predicting Postimplantation Syndrome After Endovascular Aortic Repair (EVAR) and Thoracic Endovascular Aortic Repair (TEVAR)
- ClinicalTrials.gov ID
- NCT07014839
- Acronym / sponsor ID
- PIS and EVAR / UA_ES_01
- Conditions
- Postimplantation Syndrome, Endovascular Abdominal Aortic Aneurysm Repair (EVAR), Thoracic Endovascular Aortic Repair
- Keywords
- Postimplantation Syndrome, Endovascular repair of aortic aneurysms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 11 Jun 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.
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.
Detailed description
Endovascular repair of thoracic and abdominal aortic aneurysms (EVAR/TEVAR) has become a preferred alternative to open surgical repair due to its association with reduced perioperative morbidity and mortality. However, a notable proportion of patients undergoing these procedures may develop postimplantation syndrome (PIS), a systemic inflammatory response first described in 1999. Despite its clinical relevance, PIS remains poorly defined, with varying diagnostic criteria across the literature.
PIS is typically characterized by postoperative fever, fatigue, and an increase in inflammatory markers such as white blood cell (WBC) count, C-reactive protein (CRP), and interleukin-6 (IL-6). The neutrophil-to-lymphocyte ratio (NLR), a readily obtainable marker from complete blood count tests, has also gained attention as a reliable indicator of systemic inflammation. In contrast, procalcitonin levels in PIS patients often remain within normal limits, helping differentiate PIS from bacterial infections.
In this prospective observational study, 200 patients undergoing elective EVAR or TEVAR procedures under general anesthesia were included. All procedures were performed via bilateral femoral artery access using open femoral incisions. Patients were followed postoperatively and assessed for the development of PIS based on clinical and laboratory parameters.
Body temperature was measured at regular intervals, and inflammatory markers-including CRP, WBC count, IL-6, NLR, and procalcitonin-were recorded preoperatively and at 24, 48, and 72 hours postoperatively. PIS was defined as the presence of fever (>38°C) in association with elevated CRP and/or leukocytosis, in the absence of any clinical or microbiological evidence of infection.
Preliminary results showed that patients who developed PIS had significantly higher postoperative levels of WBC, CRP, IL-6, and NLR, while procalcitonin levels remained normal, supporting a non-infectious inflammatory etiology. Imaging and laboratory evaluations ruled out alternative sources of infection. No significant differences were observed in operative time or graft type between patients with and without PIS.
All data were collected prospectively and analyzed using the SPSS statistical software. The study aims to clarify the diagnostic criteria of PIS by identifying specific laboratory biomarkers that can reliably differentiate PIS from other postoperative complications, particularly infection. Furthermore, by better understanding the inflammatory response following EVAR/TEVAR, the study may contribute to improved postoperative management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Implantation Syndrome: Lab Trends after EVAR/TEVAR | – | Procedure: Endovascular Aortic InterventionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Endovascular Aortic InterventionThis 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. | Procedure or surgery | Post-Implantation Syndrome: Lab Trends after EVAR/TEVAR |
Primary outcome
Evaluation of Postimplantation Syndrome (PIS) Incidence
Time frame: 0-8 days
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 (%)
5 secondary outcomes
C-reactive Protein (CRP) Level
Time frame: within first 72 hours postoperatively
White Blood Cell (WBC) Count
Time frame: within first 72 hours postoperatively
Interleukin-6 (IL-6) Level
Time frame: within first 72 hours postoperatively
Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: within first 72 hours postoperatively
Procalcitonin (PCT) Level
Time frame: within first 72 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Results publication: PubMed 38122858D'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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available due to institutional policies and the potential for overlapping use of the same dataset by other researchers within the institution. However, data may be shared upon reasonable request, provided that appropriate ethical approvals and data-sharing agreements are in place
Related trials for Postimplantation Syndrome
Not yet recruiting
Steroid Treatment to Prevent Thoracic Endovascular Aortic Repair Postimplantation Syndrome
Postimplantation Syndrome, Myocardial Injury
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. This study is not recruiting at the moment.
umit arslan principal investigator
Ataturk University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postimplantation Syndrome and Endovascular Abdominal Aortic Aneurysm Repair (EVAR), run by Ataturk University at 3 sites in Turkey (Türkiye).
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Postimplantation Syndrome (PIS) Incidence (time frame: 0-8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07014839, which also lists 1 linked publication.
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 11 Jun 2025.