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出境医 / 临床实验 / 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)

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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Study Description

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

Study Design

Layout table for study information

Study Type :	Observational
Actual 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
Actual Primary Completion Date :	December 14, 2020
Actual Study Completion Date :	December 14, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Layout table for eligibility information

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.

Contacts and Locations

Locations

Layout table for location information

Italy
San Raffaele Hospital
Milano, Italy, 20132

Sponsors and Collaborators

IRCCS San Raffaele

Tracking Information

First Submitted Date

May 16, 2019

First Posted Date

May 22, 2019

Last Update Posted Date

December 16, 2020

Actual Study Start Date

May 15, 2019

Actual Primary Completion Date

December 14, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

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.

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

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

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)

Brief Summary

Detailed Description

Not Provided

Study Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

patient with thoracoabdominal or para-renal aortic aneurysm

Condition

Aortic Aneurysm, Thoracoabdominal
Para-renal Aortic Aneurysms

Intervention

Not Provided

Study Groups/Cohorts

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.

Publications *

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.
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):165-72. doi: 10.1583/11-3772.1.
Bilman V, Cambiaghi T, Grandi A, Carta N, Melissano G, Chiesa R, Bertoglio L. Anatomical feasibility of a new off-the-shelf inner branch stent graft (E-nside) for endovascular treatment of thoraco-abdominal aneurysms. Eur J Cardiothorac Surg. 2020 Dec 1;58(6):1296-1303. doi: 10.1093/ejcts/ezaa276.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Completed

Actual Enrollment

562

Original Estimated Enrollment

Same as current

Actual Study Completion Date

December 14, 2020

Actual Primary Completion Date

December 14, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 90 Years (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Italy

Removed Location Countries

Administrative Information

NCT Number

NCT03959670

Other Study ID Numbers

E-nside study

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Bertoglio Luca, IRCCS San Raffaele

Study Sponsor

IRCCS San Raffaele

Collaborators

Not Provided

Investigators

Not Provided

PRS Account

IRCCS San Raffaele

Verification Date

December 2020

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麻省总医院
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密歇根大学医院
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倉敷中央医院
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順天堂医院
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藤田医科大学医院（原藤田保健大学医院)
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北里大学医院
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東京医科大学医院
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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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