To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease

Trial ID or NCT#

NCT00757003

Status

not recruiting iconNOT RECRUITING

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.

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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
    1. * \<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. 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.
  2. 6. Female of child bearing age with positive pregnancy test.
View All Criteria
Show Less

Investigator(s)

Daniel Sze, MD, PhD
Daniel Sze, MD, PhD
Interventional radiologist
Professor of Radiology (Interventional Radiology)
Michael Fischbein
Michael Fischbein
Cardiothoracic surgeon
Thelma and Henry Doelger Professor of Cardiovascular Surgery
D. Craig Miller, M.D.
R. Scott Mitchell
John D. Louie, MD
John D. Louie, MD
Interventional radiologist
Clinical Professor, Radiology
WILLIAM T. KUO, MD, FSIR, FCCP, FSVM, FACR, FCIRSE
WILLIAM T. KUO, MD, FSIR, FCCP, FSVM, FACR, FCIRSE
Interventional radiologist
Professor of Radiology (Interventional Radiology)
Nishita Kothary, MD
Nishita Kothary, MD
Interventional radiologist
Professor of Radiology (Interventional Radiology)
Lawrence "Rusty" Hofmann, MD
Lawrence "Rusty" Hofmann, MD
Interventional radiologist
Professor of Radiology (Interventional Radiology)
David Hovsepian, MD
David Hovsepian, MD
Interventional radiologist, Radiologist
Clinical Professor, Radiology - Pediatric Radiology

Contact us to find out if this trial is right for you.

Contact

Archana Verma
6507360959

View on ClinicalTrials.gov