Juxtarenal Aortic Aneurysms, Suprarenal Aortic Aneurysms, Type IV Thoracoabdominal Aortic Aneurysms
Conditions
Keywords
Aortic aneurysm
Brief summary
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.
Detailed description
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.
Interventions
DEVICECustom-made Zenith® Fenestrated AAA Endovascular Graft:
The graft will be inserted through arteries in the groin (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.
Sponsors
Gustavo S Oderich
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects who have die at 30 days post treatment | 30 days post treatment] | Deaths 30 days after treatment |
| Number of subjects who experience a Major Adverse Event at 30 days post treatment | 30 days post treatment | A Major Adverse Event includes any of the following: bowel ischemia, myocardial infarction (heart attack), paraplegia, renal failure, respiratory failure, stroke, or blood loss greater than 1000 ml. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire | 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 | 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. |
Countries
United States
Contacts
CONTACTAndrea C Martinez, MS
CONTACTYing Huang, MD, PhD
PRINCIPAL_INVESTIGATORGustavo S. Oderich, MD
Baylor College of Medicine
Outcome results
None listed