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Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

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ClinicalTrials.gov Identifier: NCT00483249
Recruitment Status : Recruiting
First Posted : June 6, 2007
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Timothy Chuter, MD, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE June 5, 2007
First Posted Date  ICMJE June 6, 2007
Last Update Posted Date July 16, 2020
Study Start Date  ICMJE May 2005
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
Successful implantation of TAAA branched stent-graft. [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
Long term success of TAAA branched stent-graft treatment. [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
Official Title  ICMJE Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
Brief Summary This is a study to assess the safety and effectiveness of endovascular treatment of thoracoabdominal (TAAA) and paravisceral abdominal (PVAAA) aortic aneurysms. The investigational operation involves placing a stent-graft over the aortic aneurysm.
Detailed Description A TAAA or PVAAA is an abnormal enlargement of the aorta, the main artery in the chest and abdomen. The standard operation for TAAA of PVAAA is performed through a long incision extending down the side of the chest and the front of the abdomen. In the standard operation, the weak area of the aorta is replaced with a fabric sleeve (graft). The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents). The combination of a stent and a graft is known as a stent-graft. Compared with standard operation, the potential advantages of endovascular TAAA/PVAAA repair include less pain, less disturbance of intestinal function, a lower risk of pulmonary or cardiac complications and shorter hospital stay. The main disadvantage of endovascular TAAA/PVAAA is an unknown success rate.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Thoracoabdominal Aortic Aneurysm
  • Paravisceral Abdominal Aortic Aneurysm
Intervention  ICMJE Device: Endovascular Branched Stent-Graft
Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.
Study Arms  ICMJE Experimental: Interventional
Endovascular Branched Stent-Graft: The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents).
Intervention: Device: Endovascular Branched Stent-Graft
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2017)
250
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2007)
55
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Aortic aneurysms:

    • greater than or equal to 6 cm in diameter in men,
    • greater than or equal to 5.5 cm in diameter in women,
    • and/or larger than 5 cm in diameter and enlarging at a rate of more than 5 mm/year,
    • and/or iliac aneurysms larger than 4 cm in diameter.
  2. Anticipated mortality comparable to published rates with conventional surgical treatment.
  3. Life expectancy more than 2 years.
  4. Ability to give informed consent.
  5. Willingness to comply with follow-up schedule.
  6. Suitable arterial anatomy for endovascular repair.

Exclusion Criteria

  1. Free rupture of the aneurysm.
  2. Pregnancy.
  3. Known allergy to Nitinol, stainless steel, or polyester.
  4. Unwillingness or inability to comply with the follow up schedule.
  5. Serious systemic or groin infection.
  6. Uncorrectable coagulopathy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Linda M Reilly, MD 415 353 4366 linda.reilly2@ucsf.edu
Contact: Warren J Gasper, MD 415 750 2115 warren.gasper@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00483249
Other Study ID Numbers  ICMJE 10-02810
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Timothy Chuter, MD, University of California, San Francisco
Study Sponsor  ICMJE Timothy Chuter, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Linda M Reilly, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP