Brief Title
Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
Official Title
Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
Brief 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.
Study Type
Interventional
Primary Outcome
Freedom From Aneurysm Rupture
Condition
Abdominal Aortic Aneurysm
Intervention
Endovascular Aneurysm Repair
Study Arms / Comparison Groups
Endovascular Aneurysm Repair
Description: Investigational stent-graft implant to exclude aneurysm
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
401
Start Date
September 1998
Completion Date
October 2017
Primary Completion Date
October 2017
Eligibility Criteria
Inclusion Criteria: - The aneurysm is >/= 5 cm or larger, or with a high risk of rupture due to its shape, history of growth, symptoms, or the presence of a large (>2 cm) iliac aneurysm - Anticipated mortality greater than 10 percent with conventional surgery - Life expectancy greater than 2 years - Suitable arterial anatomy - Absence of systemic disease or allergy that precludes an endovascular repair - Capable of giving informed consent and willingness to comply with the follow-up schedule Exclusion Criteria: - Pregnancy - History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately - Allergy to stainless steel or polyester - Unwilling to comply with the follow-up schedule - Serious or systemic groin infection - Coagulopathy, other than coumadin therapy - Inability to give informed consent
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Matthew J Eagleton, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00583414
Organization ID
G980198
Secondary IDs
IRB 3264
Responsible Party
Principal Investigator
Study Sponsor
The Cleveland Clinic
Study Sponsor
Matthew J Eagleton, MD, Principal Investigator, The Cleveland Clinic
Verification Date
January 2019