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 : April 29, 2020
|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|
This is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development.
The study is a prospective, non-randomized, non-blinded, single-arm, single-center study.
The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.
|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.|
|Actual Study Start Date :||August 2013|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
The study will include patients treated by endovascular aortic repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft. The graft includes combinations of scallops, holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.
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.
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): NCT01937949
|Contact: Vickie M Treder, LPN||507-422-6798||RSTEndovascularResearch@mayo.edu|
|Contact: Alisa M Diderrich, RN||507-422-6798||RSTEndovascularResearch@mayo.edu|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Vickie M Treder, RN 507-422-6798 RSTEndovascularResearch@mayo.edu|
|Contact: Alisa M Diderrich, RN 507-422-6798 RSTEndovascularResearch@mayo.edu|
|Principal Investigator: Gustavo S Oderich, MD|
|Principal Investigator:||Gustavo Oderich, MD||Mayo Clinic|