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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03959670
Other study ID # E-nside study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2019
Est. completion date December 14, 2020

Study information

Verified date December 2020
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 562
Est. completion date December 14, 2020
Est. primary completion date December 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Italy San Raffaele Hospital Milano

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Chuter TA, Rapp JH, Hiramoto JS, Schneider DB, Howell B, Reilly LM. Endovascular treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2008 Jan;47(1):6-16. Epub 2007 Nov 5. — View Citation

Sobocinski J, d'Utra G, O'Brien N, Midulla M, Maurel B, Guillou M, Azzaoui R, Roeder B, Resch TA, Haulon S. Off-the-shelf fenestrated endografts: a realistic option for more than 70% of patients with juxtarenal aneurysms. J Endovasc Ther. 2012 Apr;19(2):1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. between January 2007 and January 2017
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