Complex Aortic Aneurysm Repair With Fenestrated Stent Grafts
Study type: Interventional What is this?
Describes 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 phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-002880
NCT ID: NCT01937949
Sponsor Protocol Number: 13-002880
About this study
This study will compare two groups of subjects with complex abdominal aortic aneurysms. It will compare their clinical outcomes and quality of life measures. The group being treated in this study will have their aneurysms repaired by an endovascular approach using Zenith® Fenestrated AAA Endovascular Graft. This group will be compared to a group of 461 patients (historical cohort) whose complex aneurysms were treated by open surgical repair.
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. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
General Inclusion Criteria
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:
- 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.
General Exclusion Criteria
- 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 us for help.