Status:
WITHDRAWN
Post Implant Syndrome After EVAR and EVAS (INSPIRE Study)
Lead Sponsor:
Rijnstate Hospital
Conditions:
Abdominal Aortic Aneurysm
Inflammatory Response
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Retrospective data have shown that active sac management, as applied in EVAS, reduces the incidence of the post-implant syndrome. All-cause and cardiac mortality at one-year seems to be lower after EV...
Detailed Description
Endovascular sealing of abdominal aortic aneurysms (EVAS) is a new technique to treat infrarenal abdominal aortic aneurysms (AAA), which can be performed more expeditiously than endovascular aneurysm ...
Eligibility Criteria
Inclusion
- Elective EVAR/EVAS
- Ability and willingness to provide written informed consent
- Age \>50 years
Exclusion
- Complex EVAR or EVAS, including iliac branched and supra-renal repairs (pre-planned visceral chimneys, fenestrations or branches)
- Ruptured or symptomatic AAA
- Planned internal iliac artery embolization
- Acute or chronic inflammatory illness (i.e. upper respiratory tract infection)
- Active rheumatoid arthritis
- Inflammatory bowel disease, etc.)
- Inflammatory and mycotic aneurysms
- Planned associated surgical procedure (i.e. iliac conduit, femoral endarterectomy, etc.)
- Previous aortic surgery (open or endovascular)
- Untreated malignancy
- Major surgery six weeks before EVAR/EVAS
- Ongoing or recent immunosuppressive treatment, including corticosteroid use
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03763812
Start Date
December 1 2019
End Date
December 1 2021
Last Update
March 29 2019
Active Locations (7)
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1
Marienhospital Kevelaer
Kevelaer, Germany
2
Rijnstate
Arnhem, Netherlands
3
Auckland City Hospital
Auckland, New Zealand
4
University Hospital No.1
Bydgoszcz, Poland