NCT03446287

Brief Summary

This is a prospective, non-randomized, single center, data collection study of patients treated with open surgical repair (OR) for complex aortic aneurysms (CAAs).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jul 2021Dec 2026

First Submitted

Initial submission to the registry

February 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
3.4 years until next milestone

Study Start

First participant enrolled

July 16, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

5.4 years

First QC Date

February 21, 2018

Last Update Submit

February 19, 2026

Conditions

Aortic Aneurysm, Abdominal

Outcome Measures

Primary Outcomes (1)

  • Change in health-related quality of life after open repair as measured by the Short-Form General Health Survey (SF-36)

    The SF-36 consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).

    baseline, 5 years post repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing open repair (OR) for complex aortic aneurysms (CAAs) at Mayo Clinic, Rochester, Minnesota will be enrolled.

You may qualify if:

  • Patients undergoing elective, emergent or urgent OR for CAAs, including:
  • Abdominal aortic aneurysms (AAA) not eligible for endovascular aneurysm repair (EVAR), including 1) Infrarenal AAA with complex aneurysm morphology 2) Short neck infrarenal AAA 3) Juxtarenal AAA 4) Suprarenal AAA
  • Thoracoabdominal aortic aneurysms (TAAA) (Type I - IV)
  • Chronic aortic dissections

You may not qualify if:

  • Patients who refuse to participate the study
  • Patients age \< 18 years
  • Pregnant breastfeeding patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Jill Colglazier, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Haen

CONTACT

507-422-6798RSTEndovascularResearch@mayo.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2018

First Posted

February 26, 2018

Study Start

July 16, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)