Elective Treatment Rates and Surgical Non-eligibility Among Men and Women With Intact Abdominal Aortic Aneurysms

NCT05346289 | Completed

• 1 other identifier: ESPN201689310422
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim is to determine the frequency by which women and men with intact abdominal aortic aneurysms (AAA) are treated with elective surgery at three vascular outpatient clinics in Europe, and to investigate whether the reasons to refrain from elective surgery differ between the sexes.

Conditions

Abdominal Aortic Aneurysm; Abdominal Aortic Aneurysm Without Rupture; Aneurysm; Aortic Aneurysm; Aneurysm Abdominal

Keywords

Sex differences; Elective treatment rate; Surgical eligibility; Surgical treatment; Conservative treatment; Untreated

Outcome Measures

Primary Outcomes (2)

• Final Elective Treatment Status

  Relative frequency of women and men that were electively treated or left untreated, the latter group subcategorized into patients who did or did not reach the diameter threshold for surgical treatment (50 mm women, 55 men).

  End of follow-up in December 2021 with maximal possible follow-up of seven years.

• Sex-Specific Reasons for Remaining Untreated

  Frequency distribution of underlying reasons behind non-treatment among those men and women who reached the treatment threshold. Primary reason registered as patient- (comorbidity, patient's wish) or AAA-related (morphology).

  Evaluated at the time of the conservative treatment decision during maximal follow-up of seven years.

Secondary Outcomes (2)

• Rupture Rate

  Study end December 2021.

• Mortality Rate

  Study end December 2021.

Study Arms (2)

Women

Procedure: Elective surgery for intact AAA

Men

Procedure: Elective surgery for intact AAA

Interventions

Elective surgery for intact AAA PROCEDURE

Elective surgery including the following modalities: open repair, endovascular repair (EVAR), fenestrated end-vascular repair (FEVAR).

Men; Women

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All men and women diagnosed with an intact abdominal aortic aneurysm (ICD10 classification I71.4) and who fulfill the inclusion diameter criterion and none of the exclusion criteria are consecutively included from January 2014 and onwards at three vascular outpatient departments in Europe (Karolinska University Hospital, Stockholm, Sweden; St. Olav Hospital, Trondheim, Norway; Medical University of Graz, Graz, Austria) until reaching prespecified study target size according to power calculation (200 women, 200 men).

You may qualify if:

• Intact abdominal aortic aneurysm 30 mm or larger in men and women irrespective of underlying pathogenesis (atherosclerotic, mycotic, previous dissection).

You may not qualify if:

• Previous aortic surgery or surgical treatment for AAA
• Ruptured AAA at index contact

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Medical University of Graz: collaborator
• St. Olavs Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (18)

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• Talvitie M, Aldstedt-Nyronning L, Stenman M, Roy J, Cohnert T, Hultgren R. Women with large intact abdominal aortic aneurysms remain untreated. J Vasc Surg. 2023 Sep;78(3):657-667.e5. doi: 10.1016/j.jvs.2023.05.025. Epub 2023 May 20.

  PMID: 37211143 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm; Aortic Aneurysm

Interventions

Elective Surgical Procedures

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., Senior Consultant

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: June 1, 2020
• Primary Completion: February 14, 2022
• Study Completion: November 1, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)