PreOperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome (POMTEVAR)

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

POMTEVAR trial is a multicenter, open-label and prospective random controlled study. Approximately 158 patients will be randomly allocated to thoracic endovascular repair (TEVAR) alone group or TEVAR plus methylprednisolone group and managed with respective treatment strategies. All study patients will be followed up in the outpatient clinic and undergo CT scans after 3 months from randomization. The primary objective is to test the hypothesis that PIS is lower in TEVAR plus methylprednisolone group than that in TEVAR alone group. The secondary objective is to test the hypothesis that changes of postoperative inflammatory indicators, incidence of postoperative acute renal failure and postoperative delirium, postoperative pain score are lower in TEVAR plus methylprednisolone group than that in TEVAR alone. In addition, 3-month all-cause death, 3-month major adverse cardiovascular events, 3-month aorta-related adverse events and 3-month aortic remodeling are compared between groups.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Provincial People's Hospital
• Collaborators: Shenzhen People's Hospital; The First Affiliated Hospital of Guangzhou Medical University
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. Age >18 years;

2. Be confirmed as Stanford type B aortic dissection by aorta computed tomography;

3. From onset to first clinical attach <90 days;

4. The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form;

5. Availability for the appropriate follow-up visits during the follow-up period;

6. Capability to follow all study requirements.

Exclusion Criteria:

1. Laboratory examination in the last 3 months suggested severe renal dysfunction (serum creatinine >176.8umol/L or estimated creatinine clearance eGFR <30ml/min;

2. Laboratory examination in the last 3 months suggested severe liver dysfunction (ALT> 2x Max or TBIL> 2x Max);

3. Diabetics with poor glycemic control: fasting blood glucose ≥13.9mmol/L or hBA1c ≥8.5%;

4. Severe hypokalemia (Serum potassium ion concentration was less than 2.5mmol/L);

5. HIV positive, hepatitis B or C positive;

6. Immune inflammatory diseases (except skin and respiratory diseases that can be treated locally);

7. Glaucoma;

8. Gastric or duodenal ulcer;

9. Active infection (persisting body temperature >38℃; etiological evidence or imaging evidence);

10. On immunosuppressive therapy;

11. Patients with malignant tumor whose life expectancy is less than 1 year;

12. Genetic diseases, including Turner syndrome, Marfan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome and other connective tissue diseases;

13. Rheumatic immune diseases, including multiple arteritis, giant cell arteritis, polyarteritis nodosum, etc;

14. Pregnant women;

15. Severe mental illness;

16. Poor compliance, difficult to cooperate with follow-up;

17. Participate in another investigationdrug or medical device study or another investigationstudy of an approved drug or medical device within 30 days prior to the first visit of the current study;

18. Any conditions or laboratory findings that the investigator considers inappropriate for inclusion.