To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2001 |
| End Date: | May 2014 |
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.
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.
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
evaluation will include reviewing your medical history, a physical examination, and special
x-rays. These special x-rays are called CT scans and angiograms. Your doctor will explain
what tests you will have done. A CT scan is a special x-ray that allows your doctor to see
the size and shape of your aorta and your arteries. An angiogram uses a catheter (a hollow
tube) that is placed into your arteries. Both tests use dye that can be seen on x-rays to
see how the blood flows through your aorta and the surrounding arteries; for the CT scan it
will be injected into a vein, and for the angiogram it is injected through the catheter into
your arteries. These tests would be conducted whether or not you were participating in this
research study. Your doctor will use this type of testing to determine if you are eligible
to participate in this research study and as part of your follow-up care. Currently there
are two aortic stent grafts manufactured by W.L. Gore & Associates that are approved by the
FDA for experimental use. Your doctor will determine which device is more appropriate to
treat your condition.
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
evaluation will include reviewing your medical history, a physical examination, and special
x-rays. These special x-rays are called CT scans and angiograms. Your doctor will explain
what tests you will have done. A CT scan is a special x-ray that allows your doctor to see
the size and shape of your aorta and your arteries. An angiogram uses a catheter (a hollow
tube) that is placed into your arteries. Both tests use dye that can be seen on x-rays to
see how the blood flows through your aorta and the surrounding arteries; for the CT scan it
will be injected into a vein, and for the angiogram it is injected through the catheter into
your arteries. These tests would be conducted whether or not you were participating in this
research study. Your doctor will use this type of testing to determine if you are eligible
to participate in this research study and as part of your follow-up care. Currently there
are two aortic stent grafts manufactured by W.L. Gore & Associates that are approved by the
FDA for experimental use. Your doctor will determine which device is more appropriate to
treat your condition.
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.
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