NCT00583414

Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.

Detailed description

This study is a prospective, non-randomized evaluation of endovascular aneurysm repair in high-risk patients. The purpose of this study is to determine whether this endovascular prosthesis is safe and effective for the intended use of treating AAA/iliac aneurysm in patients who are at high risk for standard aneurysm surgical repair. Up to 400 patients will be enrolled at the Cleveland clinic Foundation. Baseline procedures may include angiogram, intravascular ultrasound, CT scan, physical exam, blood work and ankle-brachial index. The endovascular prosthesis is placed in the operating room under regional or general anesthesia and the procedure length is approximately 2-3 hours. Follow up evaluations will be done at 1 month, 6 months (if clinically necessary), 12 months and yearly, and may include a physical exam, CT scan, KUB, ultrasound, blood work, and an ankle-brachial index.

Conditions

• Abdominal Aortic Aneurysm
• Iliac Aneurysm
• Internal Iliac Aneurysm

Interventions

Type	Name	Description
DEVICE	Endovascular Aneurysm Repair	Endovascular exclusion of aneurysm

Timeline

• Start date: 1998-09-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2007-12-31
• Last updated: 2019-01-25
• Results posted: 2019-01-25

Locations

1 site across 1 country: United States