Thoracoabdominal Aortic Aneurysm Clinical Trial
Official title:
Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal, Thoracoabdominal and Aortic Arch Aneurysms or Dissections With Fenestrated and Branched Stent Grafts
The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm.
This is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development. Subjects will have been diagnosed with a bulge or aneurysm in their aortic arch and or abdominal aorta, which is the blood vessel in the abdomen (belly) that supplies blood to most of the lower body including major organs and the legs. The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. As an aneurysm expands, the walls become weak and may rupture, causing a major loss of blood with a high risk of death and other serious complications. To avoid this risk the aneurysm will be repaired by putting a graft inside the aneurysm. The graft will be inserted through arteries in the groin (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent-graft above and below the aneurysm. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches. The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft will be referred to as the Zenith Fenestrated-Branched System. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03637374 -
Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device
|
N/A | |
Not yet recruiting |
NCT06267573 -
Thoracoabdominal Aortic Aneurysms
|
||
Recruiting |
NCT04526938 -
Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms
|
N/A | |
Active, not recruiting |
NCT04009512 -
Endovascular Repair of Thoracoabdominal Aortic Aneurysms
|
N/A | |
Enrolling by invitation |
NCT00583817 -
Endovascular Treatment of Thoracic Aortic Disease
|
N/A | |
Completed |
NCT02528500 -
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms
|
N/A | |
Not yet recruiting |
NCT06103942 -
Automated Carbon Dioxide Angiography in Fenestrated/Branched Endovascular Abdominal Aortic Aneurysm Repair
|
||
Recruiting |
NCT05896397 -
European Aortic Data Collection Project
|
||
Recruiting |
NCT00483249 -
Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
|
N/A | |
Completed |
NCT01756911 -
Evaluation of the Safety and Efficacy of the Multilayer Stent
|
N/A | |
Recruiting |
NCT04746677 -
Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)
|
N/A | |
Recruiting |
NCT05339061 -
Physician Modified Endograft For Complex Aortic Aneurysm Repair
|
N/A | |
Recruiting |
NCT05195905 -
PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
|
N/A | |
Recruiting |
NCT02043691 -
Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies
|
N/A | |
Recruiting |
NCT03728985 -
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
|
N/A | |
Recruiting |
NCT03093857 -
Investigation of the Cerebrospinal Fluid and Further Tissue Samples for Biomarker Indicating Spinal Ischemia and Organ Failure in Patients With Thoracoabdominal Aortic Aneurysm
|
N/A | |
Recruiting |
NCT01524211 -
Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
|
N/A | |
Recruiting |
NCT05954793 -
A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System (INNER-B-APAC)
|
||
Recruiting |
NCT05224219 -
Modified Preloaded System for Renal Arteries in Fenestrated Endografting (MPSRA)
|
||
Completed |
NCT05956873 -
Endovascular Aortic Repair of Free and Contained Ruptured Thoraco-Abdominal Aortic Aneurysm
|