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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)

NCT ID: NCT03959670

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

562 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-15

Study Completion Date

2020-12-14

Brief Summary

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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

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Conditions

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Aortic Aneurysm, Thoracoabdominal Para-renal Aortic Aneurysms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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extensive TAAA

including Crawford extent I and II TAAA

No interventions assigned to this group

Crawford extent III TAAA

No interventions assigned to this group

supra-renal aortic aneurysms

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Bertoglio Luca

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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San Raffaele Hospital

Milan, , Italy

Site Status

Countries

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Italy

References

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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. doi: 10.1016/j.jvs.2007.08.032. Epub 2007 Nov 5.

Reference Type RESULT
PMID: 17980540 (View on PubMed)

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.

Reference Type RESULT
PMID: 22545880 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33057585 (View on PubMed)

Other Identifiers

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E-nside study

Identifier Type: -

Identifier Source: org_study_id