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Clinical Outcomes and Quality of Life Measures in Patients Treated With Open Surgical Repair for Complex Aortic Aneurysms

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ClinicalTrials.gov Identifier: NCT03446287
Recruitment Status : Not yet recruiting
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Gustavo S. Oderich, 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).

Condition or disease
Aortic Aneurysm, Abdominal

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical Outcomes and Quality of Life Measures in Patients Treated With Open Surgical Repair for Complex Aortic Aneurysms
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in health-related quality of life after open repair as measured by the Short-Form General Health Survey (SF-36) [ 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446287


Contacts
Contact: Jean R Wigham, R.N. 507-293-3496 Wigham.Jean@mayo.edu
Contact: Alisa M Diderrich, R.N. 507-538-8152 Diderrich.Alisa@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Jean R Wigham, RN    507-293-3496    Wigham.Jean@mayo.edu   
Principal Investigator: Gustavo Oderich, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Gustavo S Oderich, MD Mayo Clinic

Responsible Party: Gustavo S. Oderich, Professor of Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03446287     History of Changes
Other Study ID Numbers: 14-009465
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases