Trials / Active Not Recruiting
Active Not RecruitingNCT04383145
A Study in Patients With Thoracoabdominal Aortic Aneurysm Treated With the E-nside TAAA Multibranch Stent Graft System
INNER-B - A Post-market Clinical Follow-up Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- JOTEC GmbH · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | endovascular repair | Endovascular repair of thoracoabdominal aneurysm using stent grafts. |
Timeline
- Start date
- 2020-07-15
- Primary completion
- 2025-02-01
- Completion
- 2030-02-28
- First posted
- 2020-05-12
- Last updated
- 2026-02-17
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04383145. Inclusion in this directory is not an endorsement.