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

Recruiting

• Conditions: Aortic Aneurysm, Abdominal

• Registration Number: NCT03446287
• Lead Sponsor: Mayo Clinic

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).

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 Timeline

• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-26
• Study Start: 2021-07-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in health-related quality of life after open repair as measured by the Short-Form General Health Survey (SF-36)	baseline, 5 years post repair	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).

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States