What is the Purpose of this Study?
The purpose of this registry study is to collect data over time about the use and continuing safety of a medical device called the GORE TAG Conformable Thoracic Stent Graft with Active Control System and to observe how the device functions when treating relevant medical conditions that occur in the aorta (a large blood vessel that runs inside the chest and abdomen). Stent grafts consist of a plastic material which is surrounded on the outside by a metal frame and acts like a hose where blood can flow through it, but it also seals off diseased areas from blood flow. This is a post-market registry because it is a study that occurs after a medical device has been approved by the U.S. Food and Drug Administration (FDA). The registry will evaluate how the GORE TAG Conformable Thoracic Stent Graft with Active Control System is used in real-world medical care. There are no special procedures or extra visits needed for the registry that would be outside of what the participant’s doctor would normally do to treat their medical condition.
Eligibility
- 1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
- 2. Patient has been or is intended to be treated with an eligible registry device.\*
- 3. Patient is age ≥ 18 years at time of informed consent signature.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System Performance