A Study to Assess Temporal Changes in Reintervention Rate and the Impact of Reinterventions after Endovascular Aortic Repair (EVAR)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-004010
Sponsor Protocol Number: 19-004010
About this study
The purposes of this study are to determine temporal changes in patient reported outcomes and quality of life (QOL) associated with EVAR, factors associated with requirement for reintervention after EVAR, and the effect of reinterventions on patient reported outcomes and QOL associated.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- All patients undergoing F-BEVAR under previously specified inclusion/exclusion criteria (IRB numbers 13-002880 and 13-009409).
Exclusion Criteria:
Inclusion Criteria - IRB 13-002880
A patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made Zenith® Fenestrated AAA Endovascular Graft:
- Age ≥ 18 years old.
- Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter.
- Aneurysm with a history of growth ≥ 0.5 cm per year.
- Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.
Exclusion Criteria - IRB 13-002880
- Less than 18 years of age.
- Unwilling to comply with the follow-up schedule.
- Inability or refusal to give informed consent by the patient or a legally authorized representative.
- Pregnant or breastfeeding.
- Life expectancy < 2-years.
- Additional medical restrictions as specified in the Clinical Investigation Plan.
- Additional anatomical restrictions as specified in the Clinical Investigation Plan.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Gustavo Oderich, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available