Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-29 @ 12:29 AM
Study NCT ID:
NCT04378361
Status:
WITHDRAWN
Last Update Posted:
2024-07-25
First Post:
2020-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in Patients With Complicated Type B Aortic Dissection Treated With the E-nya Thoracic Stent Graft
Sponsor:
JOTEC GmbH
Organization:
Study Overview
Official Title:
CONFORM-TAD- A Post-market Clinical Follow-up Study in Patients With Complicated Acute, Subacute or Chronic Type B Aortic Dissection With Double Lumen Treated With the E-nya Thoracic Stent Graft System
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Expiry of CE mark.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONFORM-TAD
Brief Summary:
The CONFORM-TAD post-market clinical follow-up study is undertakento evaluate the prevention of death related to the treatment of a complicated acute, subacute or chronic type B aortic dissection with the E-nya Thoracic Stent Graft System. The secondary objective is to evaluate safety and clinical performance of the device.
Detailed Description:
In this study, patients who receive an E-nya Thoracic Stent Graft for the treatment of a complicated acute, subacute or chronic type B aortic dissection will be observed. The E-nya Thoracic Stent Graft will be implanted in accordance with the instructions for use of the E-nya Thoracic Stent Graft System and at the discretion of the treating physician.
Participating physicians will be asked to provide their observations collected during routine standard of care for patients he/she had decided to treat with the E-nya Thoracic Stent Graft System. Informed consent of the patients will be obtained to allow the use of their clinical records for the purpose of this observational study before data are being collected.
The period of data collection for each patient will be approximately 60 months from the intervention. 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.
Participating physicians will be asked to provide their observations collected during routine standard of care for patients he/she had decided to treat with the E-nya Thoracic Stent Graft System. Informed consent of the patients will be obtained to allow the use of their clinical records for the purpose of this observational study before data are being collected.
The period of data collection for each patient will be approximately 60 months from the intervention. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: