Trial ID or NCT#

NCT00757003

Status

NOT RECRUITING

Purpose

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.

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

Investigator(s)

Daniel Sze, MD, PhD
Interventional radiologist
Professor of Radiology (General Radiology) at the Stanford University Medical Center
Lawrence "Rusty" Hofmann, MD
Interventional radiologist
Professor of Radiology (General Radiology) at the Stanford University Medical Center
David Hovsepian, MD
Interventional radiologist, Radiologist
Clinical Professor, Radiology
Michael Fischbein
Cardiothoracic surgeon
Associate Professor of Cardiothoracic Surgery (Adult Cardiac Surgery) at the Stanford University Medical Center
D. Craig Miller, M.D.
Cardiovascular surgeon
Thelma and Henry Doelger Professor in Cardiovascular Surgery
R. Scott Mitchell
John D. Louie, MD
Interventional radiologist
Clinical Associate Professor, Radiology
WILLIAM T. KUO, MD, FSIR, FCCP, FSVM, FCIRSE
Interventional radiologist
Associate Professor of Radiology (General Radiology) at the Stanford University Medical Center
Nishita Kothary, MD
Interventional radiologist
Associate Professor of Radiology (General Radiology) at the Stanford University Medical Center

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

CONTACT

Archana Verma
(650) 736-0959