Status:
UNKNOWN
PreOperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome (POMTEVAR)
Lead Sponsor:
Guangdong Provincial People's Hospital
Collaborating Sponsors:
The First Affiliated Hospital of Guangzhou Medical University
Shenzhen People's Hospital
Conditions:
Methylprednisolone
Thoracic Endovascular Repair
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age \>18 years;
- Be confirmed as Stanford type B aortic dissection by aorta computed tomography;
- From onset to first clinical attach \<90 days;
- The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form;
- Availability for the appropriate follow-up visits during the follow-up period;
- Capability to follow all study requirements.
Exclusion
- Laboratory examination in the last 3 months suggested severe renal dysfunction (serum creatinine \>176.8umol/L or estimated creatinine clearance eGFR \<30ml/min;
- Laboratory examination in the last 3 months suggested severe liver dysfunction (ALT\> 2x Max or TBIL\> 2x Max);
- Diabetics with poor glycemic control: fasting blood glucose ≥13.9mmol/L or hBA1c ≥8.5%;
- Severe hypokalemia (Serum potassium ion concentration was less than 2.5mmol/L);
- HIV positive, hepatitis B or C positive;
- Immune inflammatory diseases (except skin and respiratory diseases that can be treated locally);
- Glaucoma;
- Gastric or duodenal ulcer;
- Active infection (persisting body temperature \>38℃; etiological evidence or imaging evidence);
- On immunosuppressive therapy;
- Patients with malignant tumor whose life expectancy is less than 1 year;
- Genetic diseases, including Turner syndrome, Marfan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome and other connective tissue diseases;
- Rheumatic immune diseases, including multiple arteritis, giant cell arteritis, polyarteritis nodosum, etc;
- Pregnant women;
- Severe mental illness;
- Poor compliance, difficult to cooperate with follow-up;
- 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;
- Any conditions or laboratory findings that the investigator considers inappropriate for inclusion.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT05349071
Start Date
May 1 2022
End Date
October 1 2024
Last Update
April 27 2022
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