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Glucocorticoid on the Prognosis of TEVAR

Sponsor
Changhai Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02523300
Collaborator
(none)
240
Enrollment
2
Arms
47
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Prognostic Value of Single-dose Glucocorticoid After Endovascular Repair for Aortic Dissection
Study Start Date :
Oct 1, 2015
Anticipated Primary Completion Date :
Sep 1, 2017
Anticipated Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: TEVAR+GC

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

Procedure: TEVAR
The patients will be undertaken TEVAR
Other Names:
  • thoracic endovascular aortic repair

    • Drug: Glucocorticoids
    About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group
    Other Names:
  • methylprednisolone

    		•
    Placebo Comparator: TEVAR+Vehicle

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

    Procedure: TEVAR
    The patients will be undertaken TEVAR
    Other Names:
  • thoracic endovascular aortic repair

    • Drug: saline
    The other 120 patients will be given saline as control group
    Other Names:
  • Vehicle

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Aorta-related adverse events [24 months]

    Secondary Outcome Measures

    1. 30-day mortality after TEVAR [30 days]

    2. Success rate of endovascular repair [24 months]

    3. Drug-related adverse events [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Changhai Hospital

    Investigators

    • Principal Investigator: Zaiping Jing, Doctor, Department of Vascular Surgery, Changhai Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zaiping JING, Director of Vascular Surgery Department, Changhai Hospital
    ClinicalTrials.gov Identifier:
    NCT02523300
    Other Study ID Numbers:
    • GC-AD-2015-07
    First Posted:
    Aug 14, 2015
    Last Update Posted:
    Aug 14, 2015
    Last Verified:
    Aug 1, 2015
    Additional relevant MeSH terms:
    Aneurysm, Dissecting
    Methylprednisolone
    Glucocorticoids

    Study Results

    No Results Posted as of Aug 14, 2015