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

Aortic Aneurysm, Thoracic Clinical Trial

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.

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Diseases

• NCT number: NCT00757003
• Study type: Interventional
• Source: Stanford University
• Status: Completed
• Phase: Phase 3
• Start date: October 2001
• Completion date: May 2014