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

Completed

• Conditions: Aortic Aneurysm, Thoracoabdominal; Para-renal Aortic Aneurysms

• Registration Number: NCT03959670
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-15
• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-22
• Status Verified: 2020-12
• Primary Completion: 2020-12-14
• Study Completion: 2020-12-14
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 562

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milano, Italy