Status:
NOT_YET_RECRUITING
Effect of Dexamethason on Postimplantation Syndrome After EVAR
Lead Sponsor:
Centro Hospitalar de Lisboa Central
Conditions:
Aneurysm Abdominal
Endovascular Aneurysm Repair
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is a multi center double-blinded randomized controlled superiority trial, comparing the effects on postimplantatrion syndrome of a single preoperative dose of dexamethasone vs. standard tre...
Detailed Description
Post-Implantation Syndrome (PIS) consists on an inflammatory reaction after endovascular aneurysm repair of abdominal aortic aneurysms (EVAR) whose etiology and pathophysiology is still unclear, but i...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Elective treatment for a degenerative infrarenal abdominal aortic aneurysm by implantation of an endograft
- Additional procedures, as endoanchors, proximal extension with a cuff or iliac branch device, during primary EVAR are allowed.
- Exclusion criteria:
- Mycotic aneurysms, aortic dissections and inflammatory aneurysms
- Known inflammatory or infectious diseases
- Preoperative anti-inflammatory therapeutic
Exclusion
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT06044480
Start Date
November 1 2023
End Date
May 31 2026
Last Update
September 21 2023
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