Complex Aortic Aneurysm Repair With Fenestrated Stent Grafts (IDE#1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01937949|
Recruitment Status : Recruiting
First Posted : September 10, 2013
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Juxtarenal Aortic Aneurysms Suprarenal Aortic Aneurysms Type IV Thoracoabdominal Aortic Aneurysms||Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft:||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts.|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||December 2020|
U.S. FDA Resources
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|