Post Implant Syndrome After EVAR and EVAS (INSPIRE Study)

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

Interventions

PROCEDURE

Endovascular Aneurysm Repair (EVAR)

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

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

Sponsors & Collaborators

• Rijnstate Hospital

  lead OTHER

Principal Investigators

• Michel Reijnen · Rijnstate Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-31

Primary Completion

2020-12-31

Completion

2021-12-31

Countries

• Germany
• Netherlands
• New Zealand
• Poland
• Spain

Study Locations