To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
Trial ID or NCT#
Status
Purpose
Study Type: Interventional Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety and Efficacy study Official Title: A Clinical Study of the TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Diseases for Non-Surgical Candidates under the Physician Sponsored IDE. PURPOSE OF RESEARCH: You are invited to participate in a research study for treatment of aneurysms of the descending thoracic aorta. The investigational device, called the TAG Thoracic Endoprosthesis (device) has been designed to simplify treatment of aneurysms of the descending thoracic aorta. The other pathologies treated can include pseudoaneurysms, acute and chronic dissections, penetrating ulcers, mycotic aneurysms, ruptures, fistulae, and transections.The device is made from a graft (an artificial vessel) which is surrounded on the outside by a metal mesh-like form. The device is in the shape of a tube. The device reinforces the weakened part of the aorta from the inside. Blood flows through the device to the arteries that go to your abdomen and legs. The device is folded tightly onto a catheter (a flexible, hollow tube) that is put into the aorta through an artery in your leg. Unless there is a problem, you would not need to have your chest opened.
Official Title
A Clinical Study of the TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Diseases for Non-Surgical Candidates Under the Physician Sponsored IDE.
Eligibility 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
- 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.
Investigator(s)
Contact us to find out if this trial is right for you.
CONTACT
Archana Verma
(650) 736-0959
View on ClinicalTrials.gov