[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03446287":3,"trial-entities:NCT03446287":70,"trial-summary:NCT03446287":76},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":27,"secondary_outcomes":32,"sex":33,"minimum_age":34,"maximum_age":21,"healthy_volunteers":14,"eligibility_criteria":35,"std_ages":39,"locations":42,"central_contacts":60,"overall_officials":62,"references":65,"see_also_links":66},"NCT03446287","14-009465","Clinical Outcomes of Patients Treated With Open Surgical Repair for Complex Aortic Aneurysms","RECRUITING","2026-12","2026-02","2026-02-23","2021-07-16","Mayo Clinic","OTHER",false,"This is a prospective, non-randomized, single center, data collection study of patients treated with open surgical repair (OR) for complex aortic aneurysms (CAAs).","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.\n\nDemographics, 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).\n\nPatients 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.",[18],"Aortic Aneurysm, Abdominal",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},150,"ESTIMATED",[],[28],{"measure":29,"description":30,"timeFrame":31},"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",[],"ALL","18 Years",{"inclusion":36,"exclusion":37,"raw_text":38},[],[],"Inclusion Criteria:\n\nPatients undergoing elective, emergent or urgent OR for CAAs, including:\n\n1. 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\n2. Thoracoabdominal aortic aneurysms (TAAA) (Type I - IV)\n3. Chronic aortic dissections\n\nExclusion Criteria:\n\n1. Patients who refuse to participate the study\n2. Patients age \\\u003C 18 years\n3. Pregnant breastfeeding patients",[40,41],"ADULT","OLDER_ADULT",[43],{"facility":12,"status":7,"city":44,"state":45,"zip":46,"country":47,"contacts":48,"geoPoint":57},"Rochester","Minnesota","55905","United States",[49,54],{"name":50,"role":51,"phone":52,"email":53},"Jenny Haen","CONTACT","507-422-6798","RSTEndovascularResearch@mayo.edu",{"name":55,"role":56},"Jill Colglazier, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":58,"lon":59},44.02163,-92.4699,[61],{"name":50,"role":51,"phone":52,"email":53},[63],{"name":64,"affiliation":12,"role":56},"Jill Colglazier, MD",[],[67],{"label":68,"url":69},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":71,"biomarkers":75},[72,73,74],"Abdominal Aortic Aneurysm","Aortic Dissection","Thoracoabdominal aortic aneurysm",[],{"nct_id":4,"found":77,"summary":78,"prompt_version":88},true,{"design":79,"status":80,"heading":81,"summary":82,"follow_up":83,"word_count":84,"commitments":85,"compensation":86,"drugs_mentioned":87},"This is an observational study collecting data from about 150 patients. It is a single-center study, meaning all patients are treated at one location.","completed","Observational Study of Open Surgical Repair for Complex Aortic Aneurysms","This study is looking at the results of open surgical repair (OR) for complex aortic aneurysms (bulges in the main artery of the body). It's an observational study, meaning researchers will collect information from patients who are already undergoing this surgery. The study aims to understand how open surgery affects your health-related quality of life, measured by a survey called SF-36, over five years. You may be eligible if you are 18 or older and need open surgery for certain types of abdominal or thoracoabdominal aortic aneurysms that can't be treated with other methods. The study is collecting information from about 150 patients.","Your health-related quality of life will be followed for 5 years after your surgery.",103,"You will fill out questionnaires (SF-36 and a specific aneurysm questionnaire) before surgery, and then at 4 months, 1 year, 3 years, and 5 years after surgery. You will also have office visits for follow-up.","Not stated in the trial record.",[],"v2"]