Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

NeuroTherapia, Inc.

Status: Completed

Conditions: Internal Iliac Aneurysm; Iliac Aneurysm; Abdominal Aortic Aneurysm

Treatments: Device: Endovascular Aneurysm Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT00583414

G980198

IRB 3264 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 401 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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401 participants in 1 patient group

Endovascular Aneurysm Repair

Experimental group

Description:

Investigational stent-graft implant to exclude aneurysm

Treatment:

Device: Endovascular Aneurysm Repair