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

Completed · Phase 3

Conditions studied: Aneurysm, Dissecting, Aortic Aneurysm, Thoracic

In brief

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.

Key facts

Study ID

NCT00757003

Run by

Stanford University

People needed

100

Starts

2001-10-01

Expected to finish

2014-05-01

Last updated by the study team

2017-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• >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.
• Female of child bearing age with positive pregnancy test.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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