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Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

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Disease Information

Descriptive Information
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 Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † Freedom from Aneurysm Rupture
Secondary Outcome Measure †
Condition † Abdominal Aortic Aneurysm Iliac Aneurysm Internal Iliac Aneurysm
Intervention † DeviceEndovascular Aneurysm Repair
Study Arms / Comparison Groups Endovascular Aneurysm Repair 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 † 450
Start Date † September 1998
Completion Date December 2020
Primary Completion Date December 2020
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 †† Nancy P Simpson, 216-444-9729, simpson@ccf.org
Location Countries † United States
Administrative Information
NCT ID † NCT00583414
Organization ID G980198
Secondary IDs †† IRB 3264
Responsible Party Sponsor-Investigator
Study Sponsor † Matthew Eagleton
Collaborators †† The Cleveland Clinic
Investigators † Principal Investigator: Matthew J Eagleton, MD, The Cleveland Clinic
Information Provided By
Verification Date April 2017
First Received Date † December 20, 2007
Last Updated Date April 12, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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