Not Yet RecruitingNot Applicable

Steroid Treatment to Prevent Thoracic Endovascular Aortic Repair Postimplantation Syndrome

Serbia174 participantsStarted 2026-01

Plain-language summary

Postimplantation syndrome (PIS) is a common and clinically important complication following thoracic endovascular aortic repair (TEVAR). PIS is characterized by a strong systemic inflammatory response to the stent-graft implantation and is manifested by flu-like symptoms, which include fever, increased white blood count, increased levels of acute phase proteins, and fatigue, but without a clear inflammatory and infective cause. Besides, it has been demonstrated that PIS is associated with prolonged hospital stay and increased risk for postoperative complications, including acute kidney injury, postoperative delirium, and increased postoperative pain scores. Recently, there has been increasing evidence that PIS is associated with an increased risk of major adverse cardiac events (MACE) and perioperative myocardial injury. Observational studies suggest that preoperative administration of glucocorticoids may decrease the incidence of PIS after TEVAR and EVAR procedures. However, to date, there are no randomised trials that have investigated whether preoperative administration of glucocorticoids can reduce the incidence of PIS and its associated poorer treatment outcomes following TEVAR. This randomized controlled trial was designed to investigate the effect of glucocorticoid administration on reducing the incidence and improving the outcome of patients who develop PIS after TEVAR.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consecutive patients admitted due to endovascular treatment of aortic dissection type B or thoracoabdominal aortic aneurysm in whom elective, open repair is planned. * Patients capable of giving informed consent. * Patients who are estimated to be available for long-term follow-up. Exclusion Criteria: * emergency procedures, the existence of severe renal insufficiency (serum creatinine \>176 µmol/L or estimated glomerular filtration rate \< 30 mL/min/1.73 m2), severe liver insufficiency (ALT value more than twice the upper limit or bilirubin levels more than twice the reference values), uncontrolled diabetes mellitus (fasting glycemia above 13.9 mmol/L, i.e. the value glycosylated hemoglobin over 8.5%), existence of active infection or sepsis, autoimmune disease, chronic pain syndromes, proven allergy to methylprednisolone, existence of gastric or duodenal ulcer, immunosuppressive or chemotherapy in the previous three months, active malignant disease, genetic diseases of connective tissue, pregnancy, critical lower limb ischemia, previous endovascular procedure on the aorta, preoperative administration of corticosteroids for any reason, significantly impaired cognitive status or psychiatric illness, acute peri/myocarditis, advanced heart failure, as well as voluntary refusal to participate in the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of PIS

Timeframe: 5 days postoperatively

Trial details

NCT IDNCT07328906

SponsorUniversity of Belgrade

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Igor Koncar, MD, Ph.D.

+381668300290 dr.koncar@gmail.com

View on ClinicalTrials.gov More Postimplantation Syndrome trials