Status:
COMPLETED
To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
Lead Sponsor:
Stanford University
Conditions:
Aneurysm, Dissecting
Aortic Aneurysm, Thoracic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
PURPOSE OF RESEARCH: Endovascular stent-graft repair of aortic pathologies is a minimally-invasive alternative to open surgery that may decrease morbidity and mortality, particularly in high risk pat...
Detailed Description
STUDY DESCRIPTION: There will be a maximum of 100 patients treated with the new device. You will be evaluated by your doctor to determine if you are able to participate in this research study. This e...
Eligibility Criteria
Inclusion
- Patients should be poor or high risk open surgical candidates.
- Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transection.
- Anatomy meets TAG 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 is the arch is included in the treatment segment.
- Ability to comply with protocol requirements including follow-up.
- Signed Informed Consent
Exclusion
- \>4mm 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 or alternate perfusion routes for end organ(s) provided.
- Degenerative connective tissue disease, e.g. Marfan's or Ehler's Danlos Syndrome, unless the proximal and distal implantation sites of the TAG Endoprosthesis are located with in previous surgical grafts.
- 6\. Female of child bearing age with positive pregnancy test.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00757003
Start Date
October 1 2001
End Date
May 1 2014
Last Update
March 1 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305