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

IRCCS San Raffaele562 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

562

Conditions

Aortic Aneurysm, Thoracoabdominal Para-renal Aortic Aneurysms

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- patient who underwent treatment of thoracoabdominal or para-renal aortic aneurysm at San Raffaele Hospital between January 2007 and January 2017. Exclusion Criteria: \- incomplete or inappropriate imaging quality defined as pre-operative CTAs with slice thickness \>1-mm.

Locations (1)

Outcomes

Primary Outcomes

Multi-planar and curved reconstruction of pre-operative contrast-enhanced computed tomography scans (CTA)

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.

Time frame: between January 2007 and January 2017