Anatomical Feasibility of the Off-the-shelf E-nside Multibranch Stent Graft System for Thoracoabdominal and Para-renal Aortic Aneurysms.(E-nside Study) (E-nside)
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|ClinicalTrials.gov Identifier: NCT03959670|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : February 11, 2020
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.
|Condition or disease|
|Aortic Aneurysm, Thoracoabdominal Para-renal Aortic Aneurysms|
|Study Type :||Observational|
|Estimated Enrollment :||562 participants|
|Official Title:||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)|
|Actual Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 2020|
including Crawford extent I and II TAAA
|Crawford extent III TAAA|
supra-renal aortic aneurysms
Crawford extent IV TAAA and para-renal abdominal aortic aneurysms.
- Multi-planar and curved reconstruction of pre-operative contrast-enhanced computed tomography scans (CTA) [ Time Frame: between January 2007 and January 2017 ]Number of patients (already treated in the Vascular Surgery Unit of San Raffaele Hospital) with anatomical characteristic for use (theoretic)of the new E-nside Multibranch Stent Graft System.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959670
|Contact: Luca Bertoglio, MD||+39002643 ext email@example.com|