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Trial record 2 of 4 for:    TAMBE

Anatomical Feasibility of Multibranched Off-the-shelf Endografts for Thoracoabdominal and Para-renal Aortic Aneurysms (TAMBE Study) (TAMBE)

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ClinicalTrials.gov Identifier: NCT03213795
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bertoglio Luca, IRCCS San Raffaele

Brief Summary:
Since the development of multibranched endografts a novel therapeutic option for the management of thoracoabdominal and para-renal aortic aneurysms was made accessible. The introduction of readily available off-the-shelf devices expanded the application of such technology also to those patients who could not afford to wait for a customized endograft to be designed and manufactured according to their aneurysm morphology

Condition or disease
Thoracoabdominal Aneurysms and Para-renal Aortic Aneurysms

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Study Type : Observational
Actual Enrollment : 562 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Anatomical Feasibility of Multibranched Off-the-shelf Endografts for Thoracoabdominal and Para-renal Aortic Aneurysms (TAMBE Study)
Actual Study Start Date : April 12, 2017
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. anatomical feasibility of multibranched off-the-shelf endografts in patients with thoracoabdominal and para-renal aortic aneurysms [ Time Frame: 2007-2017 ]
    evaluate the theoretical anatomical feasibility of multibranched off-the-shelf endografts in patients with thoracoabdominal and para-renal aortic aneurysms based on retrospective review of pre-operative imaging studies of the patients treated for this pathology in our Unit in the past ten years



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient who underwent treatment of thoracoabdominal or para-renal aortic aneurysm at San Raffaele Hospital in between January 2007 and January 2017.
Criteria

Inclusion criteria:

• patient who underwent treatment of thoracoabdominal or para-renal aortic aneurysm at San Raffaele Hospital in 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): NCT03213795


Locations
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Italy
San Raffaele Hospital
Milano, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bertoglio Luca, Principal Investigator, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03213795    
Other Study ID Numbers: TAMBE/39/OSR
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases