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RecruitingNCT03446287Updated Feb 23, 2026

Clinical Outcomes of Patients Treated With Open Surgical Repair for Complex Aortic Aneurysms

An observational study in Aortic Aneurysm, Abdominal, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed description

Patients in need of OR for CAAs will be placed in this prospective, non-randomized, single center, data collection study. Choice of the prosthetic graft and configuration will be based on surgeon's preference and extent of the disease. OR will be performed by vascular surgeons at Mayo Clinic, Rochester, assuming no difference in surgical techniques.

Demographics, clinical presentation, preoperative clinical and imaging assessment, intraoperative information, length of ICU stay and hospitalization, early and late mortality, major adverse events (MAEs), reintervention, rupture and QoL at different postoperative time points (4 months, 1 year, 3 years and 5 years) will be recorded according to well-designed case report forms (CRFs) and SF-36 form. Follow-up information will be obtained from office visits or mailing questionnaires (SF-36 form and CAA-specific questionnaire).

Patients will be asked to fill out the SF-36 forms preoperatively, and along with the CAA-specific questionnaire at 4 months, 1 year, 3 years and 5 years post-operatively. Physician assistants or study coordinators will interview all patients prior to treatment (during office evaluation). The follow-up assessments will be conducted by questionnaires (SF-36 and CAA-specific questionnaire) and office visits as well. If no response in 6 weeks after sending out questionnaires at each time point, telephone interview will be followed.

02

Conditions studied

  • Aortic Aneurysm, Abdominal
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

Patients undergoing elective, emergent or urgent OR for CAAs, including:

  1. 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
  2. Thoracoabdominal aortic aneurysms (TAAA) (Type I - IV)
  3. Chronic aortic dissections

Exclusion criteria

Exclusion Criteria:

  1. Patients who refuse to participate the study
  2. Patients age \< 18 years
  3. Pregnant breastfeeding patients
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
05

What researchers measure

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).

    Time frame: baseline, 5 years post repair

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Study locations

1 of 1 sites recruiting
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03446287
Lead sponsor
Mayo Clinic
Responsible party
Jill J. Colglazier (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Feb 26, 2018
Start date
Jul 16, 2021
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Feb 23, 2026

Study contacts

Jenny Haen
Contact
RSTEndovascularResearch@mayo.edu
507-422-6798
Jill Colglazier, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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