Clinical Trials Logo
  1. Home
  2. Thoracoabdominal Aortic Aneurysm
  3. NCT04526938

Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms

Thoracoabdominal Aortic Aneurysm Clinical Trial

Official title:
Clinical Outcomes, Radiation Dosage, and Quality of Life in Patients Treated With Fenestrated Stent Grafts for Complex Thoracoabdominal and Abdominal Aortic Aneurysms, Thoracoabdominal Aortic Aneurysms Secondary to Aortic Dissections

Clinical Trial Summary

The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. The primary intent of the study is to assess the safety and preliminary effectiveness of the device. Additionally, the study will assess renal function, radiation exposure, and quality of life.

Clinical Trial Description

This study is a prospective, single-center, non-randomized, single-arm study. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, computed tomography angiography (CTA) of chest, abdomen and pelvis, abdominal duplex ultrasound, creatinine measurement, quality of life questionnaire at specific, protocol-defined intervals for a period of five years following the physician-modified Cook Zenith® Alpha Endovascular Graft implant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04526938
Study type Interventional
Source Medstar Health Research Institute
Contact Jake Sutton
Phone 202-877-6624
Email joseph.a.sutton@medstar.net
Status Recruiting
Phase N/A
Start date September 20, 2021
Completion date September 2028
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
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
Recruiting NCT02089607 - Complex Abdominal, TAAA, Aortic Arch Aneurysm or Dissections With Fenestrated/Branched Stent Graft 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