An interventional study of Endovascular Aneurysm Repair (EVAR) and Endovascular Aneurysm Sealing (EVAS) in Abdominal Aortic Aneurysm and Inflammatory Response, sponsored by Rijnstate Hospital. Withdrawn at 7 sites in 5 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-03-29.
Sponsored by Rijnstate Hospital · Not applicable, Interventional, and Other
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 EVAS when compared to EVAR. Ongoing, low grade, inflammation could differ between techniques and induce cardiac damage.
This study is designed to establish whether EVAS results in a reduced post-operative inflammatory response during the first year after surgery, compared to EVAR as assessed by trends in circulating inflammatory cytokine concentration.
Study design: International prospective, comparative, explorative study. Study population: Patients scheduled to undergo infra-renal EVAR with a polyester endograft or EVAS for an infrarenal aortic aneurysm. This is an explorative study and therefore only patients who would normally receive a suitable device as part of standard treatment at the participating institutes will be recruited. Blood samples will be taken at specified time points before and after surgery.
Main study parameters/endpoints: The difference in early post-operative and long term inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome. To investigate the incidence of the post-implant syndrome, the rise in CRP, WBC and circulating cytokines, at specified time points up to 12 months after surgery and the change in aortic thrombus volume and its relationship with the inflammatory response, measured by cytokines' concentrations.
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 repair (EVAR). The difference with EVAR is that fixation and seal are provided from polymer filled endobags that are placed in the aneurysmal sac. The post-implantation syndrome (PIS) is the clinical and biochemical expression of an inflammatory response following endovascular repair of an aortic aneurysm. More specifically, the presence of fever (body temperature >38 C for ≥1 day) and leukocytosis (white blood cell count (WBC) >12.000/mL) with negative blood cultures and is occurring in over 30% cases after EVAR. It is related to prolonged hospital stay and elevated CRP levels, that in turn increase the risk on major adverse cardiac events. The literature showed that the magnitude of the post-operative inflammatory response depends on the type of endoprothesis used for EVAR and that EVAS is related to a lower post-operative CRP level, lower white blood counts, a lower temperature and less cardiac complications compared to standard EVAR.
The current study was designed to explore the occurence of the post-implant syndrome after EVAR and EVAS. This study was also designed to unravel the cytokines which are involved in the post-implant syndrome after EVAR and EVAS.
In this international, prospective, explorative study 60 patients who are scheduled for EVAR and 60 patients who are scheduled for EVAS will be included. Blood samples (for WBC and circulating cytokines (TNF-α, Interleukin (IL)-1, 1RA, 6, 10, 18, CRP), Troponin T, HsTnT, NT-pro-BNP)) will be taken at:
Patients are finished with the study after 12 months of follow-up.
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
Browse Aneurysm studies →Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients scheduled for EVAR will be included and blood samples at 7 time points will be taken.
Procedure: Endovascular Aneurysm Repair (EVAR)
Patients scheduled for EVAS will be included and blood samples at 7 time points will be taken.
Procedure: Endovascular Aneurysm Sealing (EVAS)
The following blood samples will be taken: WBC and circulating cytokines (TNF-α, Interleukin (IL)-1, 1RA, 6, 10, 18, CRP), Troponin T, HsTnT, NT-pro-BNP at these time points: * Before induction of anesthesia * At wound closure * 24 hours after surgery * 48 hours after surgery * 1 month after surgery * 6 months after surgery * 12 months after surgery
The following blood samples will be taken: WBC and circulating cytokines (TNF-α, Interleukin (IL)-1, 1RA, 6, 10, 18, CRP), Troponin T, HsTnT, NT-pro-BNP at these time points: * Before induction of anesthesia * At wound closure * 24 hours after surgery * 48 hours after surgery * 1 month after surgery * 6 months after surgery * 12 months after surgery
Change in inflammatory response between EVAS and EVAR
The change in early post-operative inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome.
Time frame: Up to 12 months after surgery.
Change in inflammatory response between EVAS and EVAR
The change in long term inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome.
Time frame: Up to 12 months after surgery.
Change in aortic thrombus volume
The change in aortic thrombus volume and its relationship with the inflammatory response, measured by cytokines' concentrations.
Time frame: Up to 12 months after surgery.
Pyrexia post operative
Post-operative pyrexia, measured at 24 and 48 hours.
Time frame: 24 to 48 hours after surgery
30-day Morbidity
30-day morbidity measured by cytokines' concentrations.
Time frame: Up to 30 days after surgery
1 year morbidity
1 year morbidity measured by cytokines' concentrations.
Time frame: Up to 12 months after surgery.
Cardiac complications
Cardiac complications (including measures of Troponin T, hsTnT, NT-proBNP) measured by cytokines' concentrations.
Time frame: Up to 12 months after surgery.
Mortality
(all-cause and cardiac) mortality measured by cytokines' concentrations.
Time frame: Up to 12 months after surgery.
This study is withdrawn, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rijnstate Hospital