Post Implant Syndrome After EVAR and EVAS (INSPIRE Study)

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Abdominal aortic aneurysm
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Brief Title

Post Implant Syndrome After EVAR and EVAS (INSPIRE Study)

Official Title

Explorative Study on the Inflammatory Response After Endovascular Aortic Aneurysm Repair and Endovascular Aneurysm Sealing.

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 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.

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 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:

        -  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

      Patients are finished with the study after 12 months of follow-up.

Study Type

Interventional

Primary Outcome

Change in inflammatory response between EVAS and EVAR

Secondary Outcome

 Change in aortic thrombus volume

Condition

Abdominal Aortic Aneurysm

Intervention

Endovascular Aneurysm Repair (EVAR)

Study Arms / Comparison Groups

 Endovascular Aneurysm Repair (EVAR)
Description:  Patients scheduled for EVAR will be included and blood samples at 7 time points will be taken.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

0

Start Date

December 2019

Completion Date

December 2021

Primary Completion Date

December 2020

Eligibility Criteria

        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, 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

Gender

All

Ages

50 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michel Reijnen, ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT03763812

Organization ID

INSPIRE study

Responsible Party

Principal Investigator

Study Sponsor

Rijnstate Hospital

Study Sponsor

Michel Reijnen, Principal Investigator, Rijnstate Hospital

Verification Date

March 2019