Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00583050
Recruitment Status : Active, not recruiting
First Posted : December 31, 2007
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Behzad Farivar, M. D., The Cleveland Clinic

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 Phase
Thoracoabdominal Aneurysm Abdominal Aortic Aneurysm Device: Endovascular Aneurysm Repair Not Applicable

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.

Layout table for study information
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
Actual 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


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




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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


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


Locations
Layout table for location information
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Behzad Farivar, M. D. The Cleveland Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Behzad Farivar, M. D., Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00583050    
Other Study ID Numbers: G010002
IRB 4281 ( Other Identifier: Cleveland Clinic IRB )
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases