Standardization of Physician-Modified Stent Grafts for Abdominal Aortic Aneurysms

NCT06585215 | Enrolling By Invitation

• 1 other identifier: ORLVasc-24-06
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores the use of physician-modified stent grafts (PMSGs) for treating abdominal aortic aneurysms that are unsuitable for open surgery or standard endovascular grafts. Custom-made fenestrated endografts are not viable in urgent or symptomatic cases due to lengthy manufacturing times. Although off-the-shelf branched devices are more readily available, they present challenges such as high costs, extensive thoracic coverage, limited long-term data, and anatomical restrictions. Parallel graft techniques are also associated with concerns regarding their durability. PMSG procedures, however, are not standardized and rely heavily on the physician's experience and expertise. The aim of this comprehensive study is to establish expert consensus on the indications, planning protocols, and procedural techniques for PMSGs.

Conditions

Abdominal Aortic Aneurysm; Endovascular Procedures; Stents; Vascular Surgical Procedures

Keywords

EVAR; endovascular aneurysm repair; emergency aneurysm repair; AAA; abdominal aortic aneurysm; 3D printed graft; PMSG; PMSGs; physician-modified stent graft; custom fenestrated endografts; off-the-shelf branched devices; off-label endovascular devices; complex aneurysm management; parallel graft techniques; standardization in PMSG; procedural standardization in PMSG; PMEG; PMEGs; physician-modified endograft; 3D printing in medical applications

Outcome Measures

Primary Outcomes (1)

• Expert Consensus on PMSG Indications and Techniques

  The expert consensus will be reached using the Delphi method (following CREDES guidelines), with three rounds planned. Consensus will be defined based on a Likert scale (1-5): * Very high consensus: median = 5 and percentage agreement ≥ 80%, IQR = 0; * High consensus: median = 4/5, percentage agreement ≥ 80%, IQR = 0; * Moderate consensus: median ≥ 4; 60%-79% agreement, IQR = 1; * Low consensus: median rating \< 4, \<60% agreement, IQR \> 1

  30.06.2025

Secondary Outcomes (2)

• Survey-Based Review of PMSG Strategies and Techniques

  30.06.2025

• Comparison of 3D-Printed Models and CT-Based Planning

  30.06.2025

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of vascular surgeons and interventional radiologists with specialized expertise in Physician-Modified Stent Grafts (PMSGs), fenestrated, or branched endografts. This population will include professionals with expertise in fenestrated, branched, and PMSGs. The survey aims to capture a global perspective, ensuring diverse representation from various healthcare systems. Participants must be willing to complete the survey online and provide informed consent to contribute their insights to this research.

You may qualify if:

• Vascular Surgeons or Interventional Radiologists
• Must have expertise in fenestrated, branched, and PMSG procedures.
• Completed the 31-question survey via the EDDDIE platform.
• Informed consent is required for participation.

You may not qualify if:

• Physicians with no complex endovascular repair experience

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

Centro Vascolare Ticino, Servizio di Chirurgia Vascolare e Angiologia

Lugano, Canton Ticino, 6900, Switzerland

Location

Related Publications (9)

• Rynio P, Gutowski P, Kazimierczak A. Physician-Modified Stent-Grafts Created in the Three-Dimensionally Aortic Template Have Better Reliability and Greater Alignment With the Target Vessels Than Stent-Grafts Modified Based on Measurements From Computed Tomography. J Endovasc Ther. 2023 Oct;30(5):769-778. doi: 10.1177/15266028221095396. Epub 2022 May 11.

  PMID: 35543452 BACKGROUND

• Bortman J, Mahmood F, Schermerhorn M, Lo R, Swerdlow N, Mahmood F, Matyal R. Use of 3-Dimensional Printing to Create Patient-Specific Abdominal Aortic Aneurysm Models for Preoperative Planning. J Cardiothorac Vasc Anesth. 2019 May;33(5):1442-1446. doi: 10.1053/j.jvca.2018.08.011. Epub 2018 Aug 9.

  PMID: 30217582 BACKGROUND

• Canonge J, Jayet J, Heim F, Chakfe N, Coggia M, Coscas R, Cochennec F. Comprehensive Review of Physician Modified Aortic Stent Grafts: Technical and Clinical Outcomes. Eur J Vasc Endovasc Surg. 2021 Apr;61(4):560-569. doi: 10.1016/j.ejvs.2021.01.019. Epub 2021 Feb 13.

  PMID: 33589325 BACKGROUND

• Mitsuoka H, Terai Y, Miyano Y, Naitou T, Tanai J, Kawaguchi S, Goto S, Miura Y, Nakai M, Yamazaki F. Preoperative Planning for Physician-Modified Endografts Using a Three-Dimensional Printer. Ann Vasc Dis. 2019 Sep 25;12(3):334-339. doi: 10.3400/avd.ra.19-00062.

  PMID: 31636743 BACKGROUND

• Georgiadis GS, van Herwaarden JA, Antoniou GA, Giannoukas AD, Lazarides MK, Moll FL. Fenestrated stent grafts for the treatment of complex aortic aneurysm disease: A mature treatment paradigm. Vasc Med. 2016 Jun;21(3):223-38. doi: 10.1177/1358863X16631841. Epub 2016 Mar 24.

  PMID: 27013644 BACKGROUND

• Rynio P, Jedrzejczak T, Rybicka A, Milner R, Gutowski P, Kazimierczak A. Initial Experience with Fenestrated Physician-Modified Stent Grafts Using 3D Aortic Templates. J Clin Med. 2022 Apr 13;11(8):2180. doi: 10.3390/jcm11082180.

  PMID: 35456273 BACKGROUND

• Haulon S, Barilla D, Tyrrell M, Tsilimparis N, Ricotta JJ 2nd. Debate: whether fenestrated endografts should be limited to a small number of specialized centers. J Vasc Surg. 2013 Mar;57(3):875-82. doi: 10.1016/j.jvs.2013.01.001.

  PMID: 23446130 BACKGROUND

• Junger S, Payne SA, Brine J, Radbruch L, Brearley SG. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations based on a methodological systematic review. Palliat Med. 2017 Sep;31(8):684-706. doi: 10.1177/0269216317690685. Epub 2017 Feb 13.

  PMID: 28190381 BACKGROUND

• Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021 Jul 20;11(4):116-129. doi: 10.5662/wjm.v11.i4.116. eCollection 2021 Jul 20.

  PMID: 34322364 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Giorgio Prouse, Dr. med.

  Centro Vascolare Ticino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: June 14, 2014
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CH (1)