Steroid Treatment to Prevent Thoracic Endovascular Aortic Repair Postimplantation Syndrome

Starting soon · Not applicable · Has a placebo group

Conditions studied: Postimplantation Syndrome, Myocardial Injury, MACE, Mortality

In brief

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.

Key facts

Study ID

NCT07328906

Run by

University of Belgrade

People needed

174

Starts

2026-01-01

Expected to finish

2029-01-01

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia — Belgrade, Serbia

Full record on ClinicalTrials.gov

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