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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03763812
Registration number
NCT03763812
Ethics application status
Date submitted
13/11/2018
Date registered
4/12/2018
Date last updated
29/03/2019
Titles & IDs
Public title
Post Implant Syndrome After EVAR and EVAS (INSPIRE Study)
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Scientific title
Explorative Study on the Inflammatory Response After Endovascular Aortic Aneurysm Repair and Endovascular Aneurysm Sealing.
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Secondary ID [1]
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INSPIRE study
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm
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Inflammatory Response
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Endovascular Aneurysm Repair (EVAR)
Treatment: Surgery - Endovascular Aneurysm Sealing (EVAS)
Other: Endovascular Aneurysm Repair (EVAR) - Patients scheduled for EVAR will be included and blood samples at 7 time points will be taken.
Other: Endovascular Aneurysm Sealing (EVAS) - Patients scheduled for EVAS will be included and blood samples at 7 time points will be taken.
Treatment: Surgery: Endovascular Aneurysm Repair (EVAR)
The following blood samples will be taken: WBC and circulating cytokines (TNF-a, 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
Treatment: Surgery: Endovascular Aneurysm Sealing (EVAS)
The following blood samples will be taken: WBC and circulating cytokines (TNF-a, 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
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in inflammatory response between EVAS and EVAR
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Assessment method [1]
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The change in early post-operative inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome.
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Timepoint [1]
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Up to 12 months after surgery.
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Primary outcome [2]
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Change in inflammatory response between EVAS and EVAR
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Assessment method [2]
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The change in long term inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome.
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Timepoint [2]
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Up to 12 months after surgery.
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Secondary outcome [1]
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Change in aortic thrombus volume
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Assessment method [1]
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The change in aortic thrombus volume and its relationship with the inflammatory response, measured by cytokines' concentrations.
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Timepoint [1]
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Up to 12 months after surgery.
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Secondary outcome [2]
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Pyrexia post operative
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Assessment method [2]
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Post-operative pyrexia, measured at 24 and 48 hours.
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Timepoint [2]
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24 to 48 hours after surgery
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Secondary outcome [3]
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30-day Morbidity
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Assessment method [3]
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30-day morbidity measured by cytokines' concentrations.
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Timepoint [3]
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Up to 30 days after surgery
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Secondary outcome [4]
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1 year morbidity
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Assessment method [4]
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1 year morbidity measured by cytokines' concentrations.
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Timepoint [4]
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Up to 12 months after surgery.
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Secondary outcome [5]
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Cardiac complications
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Assessment method [5]
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Cardiac complications (including measures of Troponin T, hsTnT, NT-proBNP) measured by cytokines' concentrations.
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Timepoint [5]
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Up to 12 months after surgery.
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Secondary outcome [6]
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Mortality
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Assessment method [6]
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(all-cause and cardiac) mortality measured by cytokines' concentrations.
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Timepoint [6]
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Up to 12 months after surgery.
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Eligibility
Key inclusion criteria
* Elective EVAR/EVAS
* Ability and willingness to provide written informed consent
* Age >50 years
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Other
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/12/2019
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2021
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Kevelaer
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Country [2]
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Netherlands
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State/province [2]
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Arnhem
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Country [3]
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New Zealand
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State/province [3]
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Auckland
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Country [4]
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Poland
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State/province [4]
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Bydgoszcz
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Country [5]
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Poland
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Bytom
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Country [6]
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Poland
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Warsaw
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Country [7]
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Spain
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State/province [7]
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Valencia
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Funding & Sponsors
Primary sponsor type
Other
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Name
Rijnstate Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03763812
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michel Reijnen
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Address
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Rijnstate Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03763812
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