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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

From the registry’s dates

  • Started Jul 2021; still recruiting 5 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 122 studies in Aortic Aneurysm, Abdominal with a site in United States — 28 open to participants now, 35 under way, 1 of them phase 3. Aortic Aneurysm, Abdominal · United States.

Planned enrollment
22nd of 32
150 · median 210
Started
2021
with 6 others
Observational
32 of 122
9 open now
Primary completion
2026-12
later than 9 of 34 live
Registered
88th of 122
by date
Lead sponsor
4 of 122
Mayo Clinic

Among the 122 studies in Aortic Aneurysm, Abdominal with a site in United States, this one is the 22nd largest by planned enrollment of the 32 observational ones, is one of 7 that started in 2021, is one of 32 observational ones, reaches primary completion later than 9 of the 34 other live ones, and was the 88th registered.

By phase

122 studies; the count open now beside each. This study's row is marked.

No phase64 · 14 open
Observationalthis study32 · 9 open
Phase 18 · 2 open
Phase 26 · 1 open
Other kind5 · 0 open
Phase 44 · 1 open
Phase 1/21 · 0 open
Phase 2/31 · 1 open
Phase 31 · 0 open

By the year they started

First in 1998; this study’s year is marked. 7 started in 2021.

Size and results

Median enrollment 94 across the 85 interventional studies, 210 across the 32 observational. Of the 73 that completed or were terminated, 39 (53%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 122 studies in Aortic Aneurysm, Abdominal with a site in United States, or all of them as a file.
02

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.

03

Conditions studied

  • Aortic Aneurysm, Abdominal
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
06

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for Dec 2026, 65 months after the start.

Of 67 non-industry observational studies under Aortic Aneurysm, Abdominal, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's planned 65 months is above that.

Counting every sponsor, half of 91 studies reached it within 48 months; a quarter within 24 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 21, 2018
First posted
Feb 26, 2018
StartActual
Jul 16, 2021
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Feb 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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