Trial Search Results

To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease

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 patients. Optimal patient selection, based on pathology and anatomy, is being defined. Technically successful implantation requires adequate assessment of pathology and anatomy, and development and execution of novel and delicate procedures that resolve the pathology while minimizing morbidity and mortality.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Device: Endovascular Stent-graft repair of descending thoracic aorta

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   1. Patients should be poor or high risk open surgical candidates.

   2. Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or
   extension including dissection and transection.

   3. Anatomy meets TAG Endoprosthesis specification criteria.

   4. 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.

   5. Ability to comply with protocol requirements including follow-up.

   6. Signed Informed Consent

Exclusion Criteria:

   1. >4mm aortic taper and inability to use devices of different diameters, to compensate
   for the taper, in the treatment area of the aorta.

   2. Significant thrombus at the proximal or distal implantation sites.

   3. Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit
   or alternate perfusion routes for end organ(s) provided.

   4. 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Archana Verma
6507360959
Not Recruiting