Clinical trial NCT00583414: Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
Official title: Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Iliac Aneurysm
Internal Iliac Aneurysm
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2007-12-31
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Freedom From Aneurysm Rupture
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Matthew J Eagleton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farivar BS, Abbasi MN, Dias AP, Kuramochi Y, Brier CS, Parodi FE, Eagleton MJ. Durability of iliac artery preservation associated with endovascular repair of infrarenal aortoiliac aneurysms. J Vasc Surg. 2017 Oct;66(4):1028-1036.e18. doi: 10.1016/j.jvs.2017.02.042. Epub 2017 May 11.
citation: Eagleton MJ, Shah S, Petkosevek D, Mastracci TM, Greenberg RK. Hypogastric and subclavian artery patency affects onset and recovery of spinal cord ischemia associated with aortic endografting. J Vasc Surg. 2014 Jan;59(1):89-94. doi: 10.1016/j.jvs.2013.07.007. Epub 2013 Nov 1.