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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 : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Bertoglio Luca, 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.


Condition or disease
Aortic Aneurysm, Thoracoabdominal Para-renal Aortic Aneurysms

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Study Type : Observational
Estimated Enrollment : 562 participants
Observational Model: Cohort
Time Perspective: Retrospective
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 : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort
extensive TAAA
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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient with thoracoabdominal or para-renal aortic aneurysm
Criteria

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.


Information from the National Library of Medicine

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


Contacts
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Contact: Luca Bertoglio, MD +39002643 ext 7381 bertoglio.luca@hsr.it

Locations
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Italy
San Raffaele Hospital Recruiting
Milano, Italy, 20132
Contact: Luca Bertoglio, MD       bertoglio.luca@hsr.it   
Contact: Tommaso Cambiaghi, MD       tommaso.cambiaghi@yahoo.it   
Sponsors and Collaborators
IRCCS San Raffaele

Publications of Results:
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Responsible Party: Bertoglio Luca, Principal Investigator, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03959670     History of Changes
Other Study ID Numbers: E-nside study
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases