Comparative study on the Inflammatory Response after Endovascular Aortic aneurysm Repair and Endovascular Aneurysm Sealing

Withdrawn

Conditions: Inflammatory response
10002363

Registration Number: NL-OMON46674

Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Elective EVAR/EVAS
- Ability and willingness to provide written informed consent
- Age *50 years

Exclusion Criteria

- 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
- 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in early post-operative and long term inflammatory response<br /><br>between EVAS and EVAR, measured by the incidence of the post-implant syndrome,<br /><br>the rise in WBC and circulating cytokines (TNF-*, Interleukin (IL)-1, 1RA, 6,<br /><br>10, 18, CRP), Troponin I, NT-pro-BNP, at specified time points up to 12 months<br /><br>after surgery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. The change in aortic thrombus volume and its relationship with the<br /><br>inflammatory response, measured by cytokines* concentrations.<br /><br>2. Post-operative pyrexia, measured at 24 and 48 hours.<br /><br>3. 30-day and 1-year morbidity, cardiac complications (including measures of<br /><br>troponin I, NT-proBNP, and (all-cause and cardiac) mortality, their<br /><br>relationship with the type of graft used and the inflammatory response,<br /><br>measured by cytokines* concentrations. </p><br>