Aortic Aneurysm, Thoracic Clinical Trial
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.
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 2014 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
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 Thoracic EXCLUDER 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 Thoracic EXCLUDER Endoprosthesis are located with in previous surgical grafts. 6. Female of child bearing age with positive pregnancy test. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Technical, Treatment and Clinical Success | 1month, 6 month and 12 month respectively | No | |
Primary | Technical, Treatment and Clinical Success | 1month, 6 month and 12 month respectively | Yes | |
Secondary | Procedural blood loss, length of hospital stay, return to activities of daily living | Through 12 months post procedure | No | |
Secondary | Outcome Measure: Procedural blood loss, length of hospital stay, return to activities of daily living | Through 12 months post procedure | Yes |
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