©2024 Stanford Medicine
To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
Not Recruiting
Trial ID: NCT00757003
Purpose
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.
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.
Stanford Investigator(s)
Daniel Sze, MD, PhD
Professor of Radiology (Interventional Radiology)
Michael Fischbein
Thelma and Henry Doelger Professor of Cardiovascular Surgery
Lawrence "Rusty" Hofmann, MD
Professor of Radiology (Interventional Radiology)
David Hovsepian, MD
Clinical Professor, Radiology
John D. Louie, MD
Clinical Professor, Radiology
WILLIAM T. KUO, MD, FSIR, FCCP, FSVM, FACR, FCIRSE
Professor of Radiology (Interventional Radiology)
Nishita Kothary, MD
Professor of Radiology (Interventional Radiology)
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 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
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 TAG Endoprosthesis are
located with in previous surgical grafts.
6. Female of child bearing age with positive pregnancy test.
Intervention(s):
device: Endovascular Stent-graft repair of descending thoracic aorta
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Archana Verma
6507360959