Glucocorticoid on the Prognosis of TEVAR

Naval Military Medical University

Status: Unknown

Conditions: Aortic Dissection

Treatments: Procedure: TEVAR; Drug: Glucocorticoids; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02523300

GC-AD-2015-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups, including a placebo group

TEVAR+GC

Experimental group

Description:

The patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR

Treatment:

Drug: Glucocorticoids

Procedure: TEVAR

TEVAR+Vehicle

Placebo Comparator group

Description:

The patients underwent TEVAR. Then saline will be given after TEVAR

Treatment:

Drug: saline

Procedure: TEVAR