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Clinical Study of Thoracic Excluder Endoprosthesis to Treat Descending Thoracic Aortic Diseases (Gore Thoracic)

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. Identifier: NCT00546312
Recruitment Status : Unknown
Verified May 2009 by Arizona Heart Institute.
Recruitment status was:  Active, not recruiting
First Posted : October 18, 2007
Last Update Posted : May 27, 2010
Information provided by:
Arizona Heart Institute

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of endovascular repair, using the Thoracic EXCLUDER Endoprosthesis, when used in the treatment of descending thoracic aortic disease as indicated by radiological testing at time of discharge, and 1, 6, 12 months and annually following implantation, and to determine the proportion of patients who experience adverse events during and after the implantation procedure, including disease-specific and overall mortality rates.

Condition or disease Intervention/treatment Phase
Descending Thoracic Aortic Disease Device: Thoracic EXCLUDER Endoprosthesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study Evaluating Use of the Thoracic EXCLUDER Endoprosthesis in the Treatment of Descending Thoracic Aortic Diseases
Study Start Date : February 2000
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Intervention Details:
  • Device: Thoracic EXCLUDER Endoprosthesis
    Stent-graft endoprosthesis is inserted by Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.

Primary Outcome Measures :
  1. Technical success [ Time Frame: following procedure ]
    Successful completion of the treatment at the initial time of the procedure defined by successful access to the arterial system, deployment, placement and patency of the Thoracic TAG Endoprosthesis at time of procedure.

  2. Treatment Success [ Time Frame: 30 days ]
    Initial technical success and exclusion of the appropriate portion of the descending thoracic aortic disease from the blood circulation, defined as the absence of aneurysm enlargement (if aneurysm present) and avoidance of rupture, without major complications within 30 days of the procedure.

  3. Clinical Success [ Time Frame: through 12 months ]
    Treatment success followed by patency of the graft, and continued exclusion of the appropriate portion of the descending thoracic aortic disease from the blood circulation, without reintervention, rupture, and any major complications through twelve months.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transections.
  • Anatomy meets Thoracic EXCLUDER Endoprosthesis specification criteria.
  • Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm.

    • < 60 angle in the aortic arch may require additional length of non- aneurysmal segment if the arch is included in the treatment segment.
  • The patient is of a "high risk" status for surgical repair. The patient is characterized by the presence of co-morbid factors and/or thoracic aortic pathology that place the patient in a category of prohibitive risk for open repair, and, without intervention, and adverse event could be anticipated within days or weeks. The patient has an ASA score of IV or V.
  • Ability to comply with protocol requirements including follow-up.
  • Signed Informed Consent Form.

Exclusion Criteria:

  • > 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta.
  • Significant thrombus at the proximal or distal implantation sites.
  • Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit provided.
  • Myocardial infarction within six weeks.
  • Degenerative connective tissue disease, e.g. Marfan's or Ehler Danlos Syndrome, unless the proximal and distal implantation sites of the Thoracic EXCLUDER Endoprosthesis are located within previously placed surgical grafts.
  • Female of child bearing potential with positive pregnancy test.

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 identifier (NCT number): NCT00546312

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United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
Arizona Heart Institute
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Principal Investigator: Edward B Diethrich, M.D. Arizona Heart Institute
Fann JI, Miller DC. Descending Thoracic Aortic Aneurysms: Glenns Thoracic and Cardiovascular Surgery.
Rutherford RB; editor; Vascular Surgery, Fourth Edition; 1995, W. B. Saunders Co.
Bergan JJ, Yao JST; editors; Aneurysms, Diagnosis and Treatment; 1982, Grune and Straton
Torchiana DF, Shin RD, Akins CW, Hilgenberg AD, et. al. Delayed management of traumatic thoracic aortic disruption. Poster abstract presented at the 35th annual meeting of the Society of Thoracic Surgeons, San Antonio, Texas, January 1999
Fann JI, Mitchell RS, Dake DC, Miller DC. Results of endovascular stent-grafting in patients with thoracic aortic aneurysm. Progress in Vascular Surgery chapter 19

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Responsible Party: Edward B. Diethrich, MD, Arizona Heart Institute Identifier: NCT00546312    
Other Study ID Numbers: G990299
First Posted: October 18, 2007    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: May 2009
Additional relevant MeSH terms:
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Aortic Diseases
Vascular Diseases
Cardiovascular Diseases