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Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

This study is currently recruiting participants.
Verified May 2013 by The Cleveland Clinic
Sponsor:
Collaborator:
Greenberg, Roy, M.D.
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00583414
First received: December 20, 2007
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Abdominal Aortic Aneurysm
Iliac Aneurysm
Hypogastric Aneurysm
 Device: Endovascular Stent-graft Implantation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
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
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: Dan Clair, MD            
Sub-Investigator: Sean Lyden, MD            
Sub-Investigator: Sunita Srivastava, MD            
Sub-Investigator: Matthew Eagleton, MD            
Sub-Investigator: Tara Mastracci, MD            
Sponsors and Collaborators
The Cleveland Clinic
Greenberg, Roy, M.D.
Investigators
Principal Investigator: Roy K Greenberg, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00583414     History of Changes
Other Study ID Numbers: G980198, IRB 3264
Study First Received: December 20, 2007
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013