Vascular Aneurysm Clinical Trial
Official title:
INNER-B - A Post-market Clinical Follow-up Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System
The INNER-B post-market clinical follow-up study is undertaken to evaluate the prevention of death related to a thoracoabdominal aneurysm when treated by the E-nside TAAA Multibranch Stent Graft System. The secondary objective is to evaluate the safety and clinical performance of the device.
In this study patients will be observed, who receive an E-nside TAAA Multibranch Stent Graft System for the endovascular treatment of a degenerative, atherosclerotic thoracoabdominal aortic aneurysm. The E-nside TAAA Multibranch Stent Graft will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the E-nside TAAA Multibranch Stent Graft System. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected. The period of data collection will be approximately 60 months from the index procedure for each patient. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04630535 -
OSA as a Remote Ischemic Preconditioning in Vascular Surgery
|
||
| Recruiting |
NCT04381507 -
A Study in Patients With a Descending TAA or PAU Treated With the E-nya Thoracic Stent Graft System
|
||
| Completed |
NCT05382611 -
miRNA in Patients With Thoracic, Abdominal and Intracranial Aneurysms
|
||
| Recruiting |
NCT04765176 -
A PMCF Study in Patients With Infrarenal Aortic Aneurysm Treated With the E-tegra Stent Graft System
|
||
| Completed |
NCT05350358 -
LeMaitre® CARDIAL Dialine II Post Market Study
|
||
| Recruiting |
NCT03606083 -
Registry in Patients With Aorto-iliac or Iliac Aneurysms
|
||
| Recruiting |
NCT05721001 -
French Registry Conducted on E-vita OPEN NEO
|
||
| Recruiting |
NCT05586503 -
EASYII - E-tegra Stent Graft System - Imaging Cohort
|
N/A |