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.
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02777593 -
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
|
N/A | |
Completed |
NCT02876263 -
Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta
|
N/A | |
Terminated |
NCT02538822 -
Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging
|
N/A | |
Completed |
NCT04930172 -
TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry
|
||
Completed |
NCT03207568 -
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
|
N/A | |
Recruiting |
NCT03010514 -
A Registry Study on Genetics and Biomarkers of Thoracic Aortic Aneurysm/Dissection
|
N/A | |
Completed |
NCT02266342 -
GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry
|
||
Recruiting |
NCT03574311 -
Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery
|
Phase 4 | |
Suspended |
NCT03410420 -
Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride
|
Phase 1 | |
Recruiting |
NCT05703893 -
Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)
|
||
Enrolling by invitation |
NCT05800743 -
Evaluation of the GORE® Ascending Stent Graft
|
N/A | |
Completed |
NCT02253082 -
Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28)
|
Phase 4 | |
Recruiting |
NCT02323581 -
Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
|
N/A | |
Active, not recruiting |
NCT03414866 -
Thoraflex Hybrid Post-Market Study
|
||
Recruiting |
NCT01985906 -
Safety and Efficacy of Multiple Overlapping Uncovered Stents for Pararenal Aortic Aneurysm Repair
|
N/A | |
Active, not recruiting |
NCT02818972 -
RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
|
N/A | |
Completed |
NCT03479164 -
Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysms
|
N/A | |
Completed |
NCT01775046 -
Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases (VALIANT CAPTIVIA France)
|
||
Recruiting |
NCT04814238 -
Minimally Invasive Aortic Root and Aorta surGery rEgistry
|
||
Completed |
NCT01756911 -
Evaluation of the Safety and Efficacy of the Multilayer Stent
|
N/A |