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Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts

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:
NCT00583050
First received: December 20, 2007
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of the study is to evaluate the role of fenestrated stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. The evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.


Condition Intervention Phase
Thoracoabdominal Aneurysm
Abdominal Aortic 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 Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts

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: 1000
Study Start Date: February 2001
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
    Research Endovascular Stent-graft
    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:

  1. At least 18 years of age.
  2. Not pregnant
  3. Willing and able to comply with two-year follow-up period.
  4. Willing and able to give informed consent prior to enrollment
  5. No known allergy to stainless steel or polyester
  6. No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately.
  7. Life expectancy greater than two years
  8. High risk candidate for open surgical repair

Exclusion Criteria:

see above

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583050

Contacts
Contact: Yuki Kuramochi, RN, BSN 216-445-4063 kuramoy@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Sub-Investigator: Daniel Clair, MD            
Sub-Investigator: Sean Lyden, MD            
Sub-Investigator: Eric Roselli, MD            
Sub-Investigator: Matthew Eagleton, MD            
Sub-Investigator: Sunita Srivastava, 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: NCT00583050     History of Changes
Other Study ID Numbers: G010002, IRB 4281
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
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 16, 2013