Mayo Clinic
Rochester, Minnesota, 55905, United States
Location status: Recruiting
NCT Number: NCT03446287
This is a prospective, non-randomized, single center, data collection study of patients treated with open surgical repair (OR) for complex aortic aneurysms (CAAs).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Rochester, Minnesota, 55905, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients undergoing elective, emergent or urgent OR for CAAs, including:
Exclusion criteria
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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