Complex Aortic Aneurysm Repair With Fenestrated Stent Grafts (IDE#1)
|Juxtarenal Aortic Aneurysms Suprarenal Aortic Aneurysms Type IV Thoracoabdominal Aortic Aneurysms||Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft:|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts.|
- Number of Subjects Who Die [ Time Frame: 30 days ]
- Number of Subjects Who Experience a Major Adverse Event [ Time Frame: 30 days ]
- Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire [ Time Frame: baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years. ]Subjects completed the SF-36 which 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).
- Number of Subjects Who Achieve Treatment Success [ Time Frame: 12 months ]
Treatment success is defined by a composite end-point, which includes all the following criteria described below:
- Technical success, defined as successful delivery and deployment of the custom-made endovascular graft with preservation of those branch vessels intended to be preserved.
- Freedom from type I or III endoleak.
- Freedom from stent-graft migration.
- Freedom from aneurysm enlargement >5mm
- Freedom from aneurysm rupture or conversion to open repair.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||January 2020 (Final data collection date for primary outcome measure)|
Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft. Instead of making a large incision in the abdomen,the physician makes two small incisions in the groin. Through these incision the devices are placed into the aorta.
Endovascular stent Stent-graft
Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft:
The graft will be inserted through arteries in the leg (called endovascular repair). Endovascular repair is a procedure that uses catheters that go inside your blood vessel to place a stent graft above and below the aneurysm. This procedure lines the aneurysm with a new lining (stent) so blood does not fill the artery any more.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01937949
|Contact: Jean R. Wigham, RNfirstname.lastname@example.org|
|Contact: Alisa M Diderrich, RN||507-538-8152||Diderrich.Alisa@mayo.edu|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Jean R. Wigham, RN 507-293-3496 email@example.com|
|Contact: Alisa M Diderrich, RN 507-538-8152 Diderrich.Alisa@mayo.edu|
|Principal Investigator: Gustavo S Oderich, MD|
|Principal Investigator:||Gustavo Oderich, MD||Mayo Clinic|