ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
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- STATUS
- Recruiting
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- End date
- Dec 31, 2027
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- participants needed
- 100
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- sponsor
- Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Summary
The ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.
The secondary objective is to evaluate the safety and clinical performance of the studied devices.
Description
In this study patients will be observed, who receive a branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®) for the endovascular treatment of aortic arch pathologies with proximal landing at zone 0. The devices 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 branch stent graft systems for aortic arch (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®). 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.
Details
| Condition | Thoracic Aortic Aneurysm, Thoracic Aortic Dissection, Stent-Graft Endoleak, Stent-Graft Stenosis, Intramural Hematoma, Aortic Diseases, Cardiovascular Diseases, Vascular Diseases |
|---|---|
| Treatment | Endovascular exclusion |
| Clinical Study Identifier | NCT05309707 |
| Sponsor | Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery |
| Last Modified on | 23 April 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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