Post Implant Syndrome After EVAR and EVAS (INSPIRE Study)

NCT03763812 | Withdrawn

• 1 other identifier: INSPIRE study
• Study Type: interventional
• Target: N/A
• Locations: 5 countries
• Sites: 7

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.

Conditions

Abdominal Aortic Aneurysm; Inflammatory Response

Keywords

EVAR; EVAS; Post implant syndrome; Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 12 months after surgery.

Secondary Outcomes (6)

• Change in aortic thrombus volume

  Up to 12 months after surgery.

• Pyrexia post operative

  24 to 48 hours after surgery

• 30-day Morbidity

  Up to 30 days after surgery

• 1 year morbidity

  Up to 12 months after surgery.

• Cardiac complications

  Up to 12 months after surgery.

Study Arms (2)

Endovascular Aneurysm Repair (EVAR)

OTHER

Patients scheduled for EVAR will be included and blood samples at 7 time points will be taken.

Procedure: Endovascular Aneurysm Repair (EVAR)

Endovascular Aneurysm Sealing (EVAS)

OTHER

Patients scheduled for EVAS will be included and blood samples at 7 time points will be taken.

Procedure: Endovascular Aneurysm Sealing (EVAS)

Interventions

Endovascular Aneurysm Repair (EVAR) PROCEDURE

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

Endovascular Aneurysm Repair (EVAR)

Endovascular Aneurysm Sealing (EVAS) PROCEDURE

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

Endovascular Aneurysm Sealing (EVAS)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective EVAR/EVAS
• Ability and willingness to provide written informed consent
• Age \>50 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (7)

Marienhospital Kevelaer

Kevelaer, Germany

Location

Rijnstate

Arnhem, Netherlands

Location

Auckland City Hospital

Auckland, New Zealand

Location

University Hospital No.1

Bydgoszcz, Poland

Location

Szpital Wojewódzki nr 4

Bytom, Poland

Location

Institution Hematologii I Transfuzjologii,

Warsaw, Poland

Location

Hospital Universitari I Politècnic La Fe

Valencia, Spain

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Michel Reijnen

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking since patients, doctor and researchers know if patients undergo EVAR or EVAS.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: December 4, 2018
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

NL (1); NZ (1); DE (1); PL (3); ES (1)