Juxtarenal Aortic Aneurysms Clinical Trial
Official title:
Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts
| NCT number | NCT01937949 |
| Other study ID # | HSC-MS-20-0968 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 2013 |
| Est. completion date | May 2030 |
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | May 2030 |
| Est. primary completion date | March 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | The University of Texas Health Science Center at Houston | Houston | Texas |
| United States | Mayo Clinic | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Gustavo Oderich | Cook Group Incorporated |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of subjects who have die at 30 days post treatment | Deaths 30 days after treatment | 30 days post treatment] | |
| Primary | Number of subjects who experience a Major Adverse Event at 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. | 30 days post treatment | |
| Secondary | Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire | 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). | baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years. | |
| Secondary | Number of Subjects Who Achieve Treatment Success | 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. |
12 months |