NCT03959670

Anatomical Feasibility of the Off-the-shelf E-nside Multibranch Stent Graft System for Thoracoabdominal and Para-renal Aortic Aneurysms.(E-nside Study)

Anatomical Feasibility of the Off-the-shelf E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) for Thoracoabdominal and Para-renal Aortic Aneurysms. (E-nside Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 562 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The study was created to evaluate the theoretical anatomical feasibility of the new E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) in patients with thoracoabdominal and para-renal aortic aneurysms based on retrospective review of pre-operative imaging studies of the patients treated with other techniques for this pathology in the vascular Unit of San Raffaele Hospital, in the past ten years. With this study, investigators want to analyze in how many cases the new prosthesis would be usable. E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) is in the pre-CE marking stage. At present, the certifying organism is evaluating the documentation for the release the CE mark certification and Declaration of Conformity.

Conditions

• Aortic Aneurysm, Thoracoabdominal
• Para-renal Aortic Aneurysms

Timeline

• Start date: 2019-05-15
• Primary completion: 2020-12-14
• Completion: 2020-12-14
• First posted: 2019-05-22
• Last updated: 2020-12-16

Locations

1 site across 1 country: Italy