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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

Tracking Information
First Submitted Date May 16, 2019
First Posted Date May 22, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date May 15, 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2019)
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 No Changes Posted
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

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 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 21, 2019)
562
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date November 2019   (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 No
Contacts
Contact: Luca Bertoglio, MD +39002643 ext 7381 bertoglio.luca@hsr.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03959670
Other Study ID Numbers E-nside study
Has Data Monitoring Committee No
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: No
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 May 2019