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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)
Scientific title
Explorative Study on the Inflammatory Response After Endovascular Aortic Aneurysm Repair and Endovascular Aneurysm Sealing.
Secondary ID [1] 0 0
INSPIRE study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm 0 0
Inflammatory Response 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in inflammatory response between EVAS and EVAR
Timepoint [1] 0 0
Up to 12 months after surgery.
Primary outcome [2] 0 0
Change in inflammatory response between EVAS and EVAR
Timepoint [2] 0 0
Up to 12 months after surgery.
Secondary outcome [1] 0 0
Change in aortic thrombus volume
Timepoint [1] 0 0
Up to 12 months after surgery.
Secondary outcome [2] 0 0
Pyrexia post operative
Timepoint [2] 0 0
24 to 48 hours after surgery
Secondary outcome [3] 0 0
30-day Morbidity
Timepoint [3] 0 0
Up to 30 days after surgery
Secondary outcome [4] 0 0
1 year morbidity
Timepoint [4] 0 0
Up to 12 months after surgery.
Secondary outcome [5] 0 0
Cardiac complications
Timepoint [5] 0 0
Up to 12 months after surgery.
Secondary outcome [6] 0 0
Mortality
Timepoint [6] 0 0
Up to 12 months after surgery.

Eligibility
Key inclusion criteria
* Elective EVAR/EVAS
* Ability and willingness to provide written informed consent
* Age >50 years
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Kevelaer
Country [2] 0 0
Netherlands
State/province [2] 0 0
Arnhem
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
Poland
State/province [4] 0 0
Bydgoszcz
Country [5] 0 0
Poland
State/province [5] 0 0
Bytom
Country [6] 0 0
Poland
State/province [6] 0 0
Warsaw
Country [7] 0 0
Spain
State/province [7] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Other
Name
Rijnstate Hospital
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03763812
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michel Reijnen
Address 0 0
Rijnstate Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03763812