Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Not Applicable

Completed

• Conditions: Internal Iliac Aneurysm; Abdominal Aortic Aneurysm; Iliac Aneurysm
• Interventions: Device: Endovascular Aneurysm Repair

• Registration Number: NCT00583414
• Lead Sponsor: The Cleveland Clinic

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 Timeline

• Study Start: 1998-09
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-28
• Study First Posted: 2007-12-31
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Results First Submitted: 2018-11-30
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-21
• Last Update Submitted: 2019-01-21
• Results First Posted: 2019-01-25
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endovascular Aneurysm Repair	Endovascular Aneurysm Repair	Investigational stent-graft implant to exclude aneurysm

Primary Outcome Measures

Name	Time	Method
Freedom From Aneurysm Rupture	2 years	Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States