D. Craig Miller, M.D.
To evaluate the safety and efficacy for GORE TAG Thoracic Endoprosthesis in the treatment of Thoracic Aortic disease
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Device: Endovascular Stent-graft repair of descending thoracic aorta
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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
Key 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 implatation sites of the Thoracic EXCLUDER Endoprosthesis are located with in previous surgical grafts.
6. Female of child bearing age with positive pregnancy test.
Additional Study Details
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.Anticipated start date:
10/2/2001Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Technical, Treatment and Clinical Access (Time frame:1 month, 6 month, 12 month and annually upto 60 months) (designated as Safety issue)
Total Number to be Enrolled:
100Total Number to be Enrolled at Stanford:
100More Information
Secondary ID(s):
- 13335 (SQL 73498)
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/18/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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