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

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Aneurysm, Abdominal

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Jenny Haen; Phone Number: 507-422-6798; Email: RSTEndovascularResearch@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Bernardo Mendes, M.D.
      • Contact: Jenny Haen; Phone Number: 507-422-6798; Email: RSTEndovascularResearch@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Bernardo Mendes, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 21, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 14-009465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No