Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2015-10-31
2019-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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TEVAR+GC
The patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR
TEVAR
The patients will be undertaken TEVAR
Glucocorticoids
About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group
TEVAR+Vehicle
The patients underwent TEVAR. Then saline will be given after TEVAR
TEVAR
The patients will be undertaken TEVAR
saline
The other 120 patients will be given saline as control group
Interventions
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TEVAR
The patients will be undertaken TEVAR
Glucocorticoids
About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group
saline
The other 120 patients will be given saline as control group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Zaiping JING
Director of Vascular Surgery Department
Principal Investigators
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Zaiping Jing, Doctor
Role: PRINCIPAL_INVESTIGATOR
Department of Vascular Surgery, Changhai Hospital
Central Contacts
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References
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Wu M, Zhang L, Bao J, Zhao Z, Lu Q, Feng R, Song C, Zhou J, Jing Z. Postoperative glucocorticoid enhances recovery after endovascular aortic repair for chronic type B aortic dissection: a single-center experience. BMC Cardiovasc Disord. 2016 Mar 25;16:59. doi: 10.1186/s12872-016-0234-2.
Other Identifiers
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GC-AD-2015-07
Identifier Type: -
Identifier Source: org_study_id
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