Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by The Cleveland Clinic
The Cleveland Clinic
Information provided by (Responsible Party):
Matthew Eagleton, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier:
First received: December 20, 2007
Last updated: August 10, 2015
Last verified: August 2015

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

Condition Intervention
Abdominal Aortic Aneurysm
Iliac Aneurysm
Hypogastric Aneurysm
Device: Endovascular Stent-graft Implantation

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Safety [ Time Frame: Undecided ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: September 1998
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endovascular Stent-graft Implantation
    Endovascular Repair of Aortic Aneurysm
    Other Name: Cook Zenith
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583414

Contact: Nancy P Simpson 216-444-9729 simpson@ccf.org

United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Sub-Investigator: Dan Clair, MD         
Sub-Investigator: Sean Lyden, MD         
Sub-Investigator: Sunita Srivastava, MD         
Principal Investigator: Matthew Eagleton, MD         
Sub-Investigator: Federico E Parodi, MD         
Sponsors and Collaborators
Matthew Eagleton
The Cleveland Clinic
Principal Investigator: Matthew J Eagleton, MD The Cleveland Clinic
  More Information

No publications provided by The Cleveland Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthew Eagleton, Staff, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT00583414     History of Changes
Other Study ID Numbers: G980198, IRB 3264
Study First Received: December 20, 2007
Last Updated: August 10, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 08, 2015