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

NCT03959670 | Completed

• 1 other identifier: E-nside study
• Study Type: observational
• Target: 562
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Aneurysm, Thoracoabdominal; Para-renal Aortic Aneurysms

Outcome Measures

Primary Outcomes (1)

• Multi-planar and curved reconstruction of pre-operative contrast-enhanced computed tomography scans (CTA)

  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.

  between January 2007 and January 2017

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient with thoracoabdominal or para-renal aortic aneurysm

You may qualify if:

• \- patient who underwent treatment of thoracoabdominal or para-renal aortic aneurysm at San Raffaele Hospital between January 2007 and January 2017.

You may not qualify if:

• \- incomplete or inappropriate imaging quality defined as pre-operative CTAs with slice thickness \>1-mm.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

Related Publications (3)

• 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.

  PMID: 17980540 RESULT

• 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.

  PMID: 22545880 RESULT

• 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.

  PMID: 33057585 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 22, 2019
• Study Start: May 15, 2019
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)