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

San Donato Group (GSD)

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT03959670

E-nside study

Details and patient eligibility

About

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.

Enrollment: 562 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

562 participants in 3 patient groups

extensive TAAA

Description:

including Crawford extent I and II TAAA

Crawford extent III TAAA

supra-renal aortic aneurysms

Description:

Crawford extent IV TAAA and para-renal abdominal aortic aneurysms.