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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Matthew Eagleton, The Cleveland Clinic
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Matthew Eagleton, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00583050
First received: December 20, 2007
Last updated: April 12, 2017
Last verified: April 2017
  Purpose
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.

Condition Intervention
Thoracoabdominal Aneurysm Abdominal Aortic Aneurysm Device: Endovascular Aneurysm Repair

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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 Matthew Eagleton, The Cleveland Clinic:

Primary Outcome Measures:
  • Freedom from Aneurysm Rupture [ Time Frame: 2 years ]
    Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan


Estimated Enrollment: 1340
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: Endovascular Aneurysm Repair
Endovascular Aneurysm Repair of TAAA/AAA with Fenestrated/Branched Stent Grafts
Device: Endovascular Aneurysm Repair
Endovascular exclusion of aneurysm
Other Name: Cook Zenith

Detailed Description:
The purpose of the study is to evaluate the role of fenestrated/branched 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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

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: 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
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, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00583050     History of Changes
Other Study ID Numbers: G010002
IRB 4281 ( Other Identifier: Cleveland Clinic IRB )
Study First Received: December 20, 2007
Last Updated: April 12, 2017
Individual Participant Data  
Plan to Share IPD: No

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 June 27, 2017