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

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ClinicalTrials.gov Identifier: NCT00583050
Recruitment Status : Recruiting
First Posted : December 31, 2007
Last Update Posted : August 24, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Thoracoabdominal Aneurysm Abdominal Aortic Aneurysm Device: Endovascular Aneurysm Repair

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1440 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts
Study Start Date : February 2001
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 )
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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