Glucocorticoid on the Prognosis of TEVAR

Aortic Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02523300
• Other study ID #: GC-AD-2015-07
• Status: Not yet recruiting
• Phase: N/A
• First received: August 11, 2015
• Last updated: August 13, 2015
• Start date: October 2015
• Est. completion date: September 2019

Study information

• Verified date: August 2015
• Source: Changhai Hospital
• Contact: Jian Zhou, Doctor
• Phone: 86-21-31161669
• Email: zhoujian1-2[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: September 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aortic Dissection

Intervention

Procedure:
• TEVAR
The patients will be undertaken TEVAR

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aorta-related adverse events		24 months	No
Secondary	30-day mortality after TEVAR		30 days	No
Secondary	Success rate of endovascular repair		24 months	No
Secondary	Drug-related adverse events		24 months	No