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Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00583414
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : December 14, 2017
The Cleveland Clinic
Information provided by (Responsible Party):
Matthew Eagleton, 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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Iliac Aneurysm Internal Iliac Aneurysm Device: Endovascular Aneurysm Repair Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
Actual Study Start Date : September 1998
Primary Completion Date : October 2017
Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Endovascular Aneurysm Repair
Investigational stent-graft implant to exclude aneurysm
Device: Endovascular Aneurysm Repair
Endovascular exclusion of aneurysm
Other Name: Cook Zenith

Primary Outcome Measures :
  1. Freedom from Aneurysm Rupture [ Time Frame: 2 years ]
    Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00583414

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Matthew Eagleton
The Cleveland Clinic
Principal Investigator: Matthew J Eagleton, MD The Cleveland Clinic

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Matthew Eagleton, Staff, The Cleveland Clinic Identifier: NCT00583414     History of Changes
Other Study ID Numbers: G980198
IRB 3264 ( Other Identifier: Cleveland Clinic IRB )
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases