Trials / Terminated
TerminatedNCT04381507
A Study in Patients with a Descending TAA or PAU Treated with the E-nya Thoracic Stent Graft System
CONFORM-TAA - a Post-market Clinical Follow-up Study in Patients with a Descending Thoracic Aortic Aneurysm or Penetrating Aortic Ulcer (PAU) Treated with the E-nya Thoracic Stent Graft System
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 1 (actual)
- Sponsor
- JOTEC GmbH · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The CONFORM-TAA post-market clinical follow-up study is undertaken to evaluate the prevention of death related to a descending aortic aneurysm or PAU when treated by the E-nya Thoracic Stent Graft System. The secondary objective is to evaluate the safety and clinical performance of the device.
Detailed description
In this study, patients who receive an E-nya Thoracic Stent Graft for the endovascular treatment of descending thoracic aortic aneurysm or PAU 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | endovascular repair | Endovascular repair of descending thoracic aneurysms or PAU using a stent graft. |
Timeline
- Start date
- 2020-06-12
- Primary completion
- 2024-07-24
- Completion
- 2024-07-24
- First posted
- 2020-05-11
- Last updated
- 2024-10-18
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04381507. Inclusion in this directory is not an endorsement.