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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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.

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Stanford University

Current Primary Outcome: Percentage of Participants With Technically Successful Implant [ Time Frame: Day 0 to Day 30 ]

The percentage of participants with technically successful implantation as assessed by the investigator is reported.


Original Primary Outcome: Technical, Treatment and Clinical Access (Time frame:1 month, 6 month, 12 month and annually upto 60 months) (designated as Safety issue)

Current Secondary Outcome:

  • Count of Participants Experiencing at Least One Endoleak Following Procedure [ Time Frame: Up to 60 months following procedure ]
    Endoleak is persistent blood flow in the aneurysm sac.
  • Overall Survival [ Time Frame: 60 months ]
    Overall survival is reported as the count of participants alive 60 months following implant procedure.


Original Secondary Outcome:

Information By: Stanford University

Dates:
Date Received: September 18, 2008
Date Started: October 2001
Date Completion:
Last Updated: January 10, 2017
Last Verified: January 2017