Clinical Trials Logo
  1. Home
  2. Thoracoabdominal Aortic Aneurysm
  3. NCT02089607

Complex Abdominal, TAAA, Aortic Arch Aneurysm or Dissections With Fenestrated/Branched Stent Graft

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02089607
Study type Interventional
Source The University of Texas Health Science Center, Houston
Contact Safa Savadi Osgouei, MD
Phone (713) 486-5361
Email Safa.savadiosgouei@uth.tmc.edu
Status Recruiting
Phase N/A
Start date March 2014
Completion date May 2030
View Details
See also
  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