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NCT Number: NCT07696884

Clinical Outcomes and Host Immune Response in Vascular Graft and Endograft Infections

ACHIEVE is a prospective observational cohort and biobank study of patients with suspected or diagnosed central vascular graft or endograft infection. The study also includes patients undergoing elective central vascular graft or endograft implantation and healthy blood donor controls. Participants undergo longitudinal clinical data collection and biospecimen sampling. The study aims to characterize clinical outcomes, host immune responses, inflammatory biomarkers, pathogen-related factors, and novel microbiological diagnostic methods, including microbial cell-free DNA sequencing, in vascular graft and endograft infections.

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Key information

Conditions

Vascular Graft Infection Aortic Graft Infection Vascular Endograft Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older.
  • Able and willing to provide informed consent.
  • For the vascular graft or endograft infection group: suspected or diagnosed vascular graft or endograft infection in a central vascular prosthesis as determined by the treating clinicians.
  • For the elective vascular graft or endograft control group: planned central vascular graft or endograft implantation.
  • For the healthy blood donor control group: active blood donor registered at Aarhus University Hospital Blood Bank.
  • For the healthy blood donor control group: no current infection or other active disease.

Exclusion criteria

  • For the elective vascular graft or endograft control group: surgery performed as an emergency procedure within 24 hours.
  • For the elective vascular graft or endograft control group: reoperation of a previously implanted vascular graft or endograft.
  • For the elective vascular graft or endograft control group: evidence suggestive of ongoing infection in the area of surgery.
  • Unable to provide informed consent.

Treatment and study plan

Primary outcomes

  1. Percentage of peripheral blood myeloid-derived suppressor cells among live PBMCs at baseline

    Time frame: At baseline/inclusion

    Percentage of live PBMCs identified as myeloid-derived suppressor cells by flow cytometry, compared between participants with vascular graft or endograft infection and elective vascular graft/endograft controls.

  2. Proportion of selected VGEI sampling events with clinically adjudicated mNGS positivity

    Time frame: At each paired VGEI sampling event from inclusion through follow-up, up to 10 years

    Selected VGEI sampling events with final consensus sample-level mNGS result classified as positive divided by all selected VGEI sampling events within the predefined clinical sampling category.

  3. Proportion of selected VGEI sampling events with clinically relevant paired blood culture positivity

    Time frame: At each paired VGEI sampling event from inclusion through follow-up, up to 10 years

    Selected VGEI sampling events with clinically relevant positive paired blood culture divided by all selected VGEI sampling events within the predefined clinical sampling category.

Secondary outcomes

  1. Proportion of selected VGEI sampling events with additional clinically relevant mNGS yield

    Time frame: At each paired VGEI sampling event from inclusion through follow-up, up to 10 years

    Selected VGEI sampling events with consensus sample-level mNGS positivity and negative paired blood culture divided by all selected VGEI sampling events within the predefined clinical sampling category.

Other outcomes

  1. Distribution of microbiological pathogens identified in VGEI participants

    Time frame: From inclusion through follow-up, up to 10 years

    Type of microorganism identified by conventional microbiology from blood, perioperative specimens, operative wounds, graft/perigraft material, or other clinically relevant foci in enrolled VGEI participants.

Study contacts

Contact information is provided by the study sponsor or research team.

Rasmus A Nielsen, MD

CONTACT

[email protected]

+4522897999

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Aalborg University
  • Central Denmark Region
  • Gødstrup Hospital
  • Randers Regional Hospital
  • Regionshospitalet Horsens
  • University of Aarhus
  • Viborg Regional Hospital

Registry information

Official study title

Analysis of Clinical Outcomes and Host Immune Response to Vascular Graft and Endograft Infections

Acronym: ACHIEVE

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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