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

Aortic Aneurysm, Abdominal Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03446287
Study type Observational
Source Mayo Clinic
Contact Jenny Haen
Phone 507-422-6798
Email RSTEndovascularResearch@mayo.edu
Status Recruiting
Phase
Start date July 16, 2021
Completion date December 2026
View Details
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