Glucocorticoid on the Prognosis of TEVAR

Not Applicable

• Conditions: Aortic Dissection
• Interventions: Procedure: TEVAR; Drug: Glucocorticoids; Drug: saline

• Registration Number: NCT02523300
• Lead Sponsor: Changhai Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2015-08
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Study First Posted: 2015-08-14
• Last Update Posted: 2015-08-14
• Study Start: 2015-10
• Primary Completion: 2017-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. age from 18 to 80, male or unpregnant female;
2. diagnosed as aortic dissection, excluding intramural hematoma and penetrating aortic ulcer;
3. complicated aortic dissection with definite indications of TEVAR;
4. voluntarily signed the informed consent form;
5. good compliance with the instructions and cooperate with follow-up.

Exclusion Criteria

1. no appropriate vessel approaches;
2. patients with connective tissue diseases (such as Marfan syndrome);
3. patients with endocrine disease,such as diabetes mellitus, or undergoing hormonotherapy;
4. bad compliance with the instructions and follow-up;
5. allergic to nitinol and contrast medium;
6. estimated life expectancy is less than 24 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEVAR+Vehicle	TEVAR	The patients underwent TEVAR. Then saline will be given after TEVAR
TEVAR+GC	Glucocorticoids	The patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR
TEVAR+Vehicle	saline	The patients underwent TEVAR. Then saline will be given after TEVAR
TEVAR+GC	TEVAR	The patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR

Primary Outcome Measures

Name	Time	Method
Aorta-related adverse events	24 months

Secondary Outcome Measures

Name	Time	Method
30-day mortality after TEVAR	30 days
Success rate of endovascular repair	24 months
Drug-related adverse events	24 months