Clinical trial NCT03446287: Clinical Outcomes of Patients Treated With Open Surgical Repair for Complex Aortic Aneurysms
Official title: Clinical Outcomes of Patients Treated With Open Surgical Repair for Complex Aortic Aneurysms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Aneurysm, Abdominal
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in health-related quality of life after open repair as measured by the Short-Form General Health Survey (SF-36)
timeFrame: baseline, 5 years post repair
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Bernardo Mendes, MD
role: PRINCIPAL_INVESTIGATOR
References: