Glucocorticoid on the Prognosis of TEVAR

Study Overview
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Brief Summary
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To explore the potential prognostic effect of glucocorticoid on the postoperative aorta-related adverse events after aortic dissections patients underwent thoracic endovascular aortic repair (TEVAR), glucocorticoid (30mg/kg) will be intravenously given within 2h after TEVAR.

Detailed Description
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This is a prospective, open, single-center, randomized controlled trial. Number of patients: 240 patients will be included and undertaken TEVAR.About 120 patients will be given glucocorticoid within 2h after TEVAR as experimental group, and the other 120 patients will be given saline as control group. Follow-up: 1. aortic computed tomographic angiography (CTA) examination 6, 12 and 24 months after TEVAR; 2. telephone or clinical follow-up at 1, 2, 3, 6, 12 and 24 months. Primary outcome measure: aorta-related adverse events. Second outcome measure: 30-day mortality after TEVAR, success rate of endovascular repair, drug-related adverse events.

Official Title
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Prognostic Value of Single-dose Glucocorticoid After Endovascular Repair for Aortic Dissection

Conditions
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Aortic Dissection

Intervention / Treatment
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* Procedure: TEVAR
* Drug: Glucocorticoids
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age from 18 to 80, male or unpregnant female; diagnosed as aortic dissection, excluding intramural hematoma and penetrating aortic ulcer; complicated aortic dissection with definite indications of TEVAR; voluntarily signed the informed consent form; good compliance with the instructions and cooperate with follow-up. Exclusion Criteria: no appropriate vessel approaches; patients with connective tissue diseases (such as Marfan syndrome); patients with endocrine disease,such as diabetes mellitus, or undergoing hormonotherapy; bad compliance with the instructions and follow-up; allergic to nitinol and contrast medium; estimated life expectancy is less than 24 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEVAR+GC<br>The patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR | Procedure: TEVAR<br>* The patients will be undertaken TEVAR<br>* Other names: thoracic endovascular aortic repair;Drug: Glucocorticoids<br>* About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group<br>* Other names: methylprednisolone;|
| Placebo Comparator: TEVAR+Vehicle<br>The patients underwent TEVAR. Then saline will be given after TEVAR | Procedure: TEVAR<br>* The patients will be undertaken TEVAR<br>* Other names: thoracic endovascular aortic repair;Drug: saline<br>* The other 120 patients will be given saline as control group<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aorta-related adverse events |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality after TEVAR |  | 30 days | 
| Success rate of endovascular repair |  | 24 months | 
| Drug-related adverse events |  | 24 months |