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Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by The Cleveland Clinic
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Matthew Eagleton, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier:
NCT00583414
First received: December 20, 2007
Last updated: October 3, 2016
Last verified: October 2016
  Purpose
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
Internal Iliac Aneurysm
Device: Endovascular Aneurysm Repair

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:
  • Freedom from Aneurysm Rupture [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan


Estimated Enrollment: 450
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)
Arms Assigned Interventions
Experimental: Endovascular Aneurysm Repair
Investigational stent-graft implant to exclude aneurysm
Device: Endovascular Aneurysm Repair
Endovascular exclusion of 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
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
Investigators
Principal Investigator: Matthew J Eagleton, MD The Cleveland Clinic
  More Information

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: October 3, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on December 02, 2016