Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic… (NCT04526938) | Clinical Trial Compass
SuspendedNot Applicable
Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms
Stopped: PI left institution
United States200 participantsStarted 2021-09-20
Plain-language summary
The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. The primary intent of the study is to assess the safety and preliminary effectiveness of the device. Additionally, the study will assess renal function, radiation exposure, and quality of life.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years old
✓. Life expectancy \> 2 year(s)
✓. Patient is considered to be at high risk of morbidity and mortality with open surgical repair
✓. A patient may be entered into the study if the patient has at least one of the following:
✓. Patient is considered to be at high risk of morbidity and mortality with open surgical repair
✓. Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
✓. Nonaneurysmal aortic segment proximal to the aneurysm (neck) with a:
✓. Minimum branch vessel diameter greater than 5 mm
Exclusion criteria
✕. Under the age of 18 years
✕. Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
What they're measuring
1
Freedom from Major Adverse Events (MAE) at 30 days
Timeframe: 30 days
2
Proportion of study subjects with treatment success at 1 year