Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2017-10-31

Brief Summary

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

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Detailed Description

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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

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Abdominal Aortic Aneurysm Iliac Aneurysm Internal Iliac Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endovascular Aneurysm Repair

Investigational stent-graft implant to exclude aneurysm

Group Type EXPERIMENTAL

Endovascular Aneurysm Repair

Intervention Type DEVICE

Endovascular exclusion of aneurysm

Interventions

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Endovascular Aneurysm Repair

Endovascular exclusion of aneurysm

Intervention Type DEVICE

Other Intervention Names

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Cook Zenith

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No