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

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 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:

Further study details as provided by The Cleveland Clinic:

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

Estimated Enrollment: 1220
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)
Arms Assigned Interventions
Experimental: Primary Arm only
Endovascular exclusions of TAAA/AAA with Fenestrated/Branched Stent Grafts
Device: Endovascular Stent-graft implantation
Research Endovascular Stent-graft
Other Name: Cook Zenith


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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: NCT00583050

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

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         
Principal Investigator: Matthew Eagleton, MD         
Sub-Investigator: Sunita Srivastava, MD         
Sub-Investigator: Federico E Prodi, MD         
Sponsors and Collaborators
Matthew Eagleton
The Cleveland Clinic
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: NCT00583050     History of Changes
Other Study ID Numbers: G010002  IRB 4281 
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
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2016