Standardization of Physician-Modified Stent Grafts for Abdominal Aortic Aneurysms

Launched by ENTE OSPEDALIERO CANTONALE, BELLINZONA · Sep 3, 2024

Keywords

ClinConnect Summary

This study is not testing a medicine or a new device in patients. It’s an observational project to create standard guidelines for using physician-modified stent grafts (PMSGs) to treat abdominal aortic aneurysms, especially when urgent cases can’t wait for custom devices or open surgery. The project has three parts: (1) a global online survey of vascular surgeons and interventional radiologists with PMSG experience, (2) a case-planning exercise where experts compare planning with 3D-printed models versus traditional CT plans, and (3) a Delphi consensus process to reach expert recommendations on when to use PMSGs, how to plan them, and how to perform the procedures.

About 100 expert participants are expected, and they must be vascular surgeons or interventional radiologists with experience in PMSGs or related techniques. Eligible participants should complete a 31-question online survey and provide informed consent; they will also take part in the planning exercise using two cases and may participate in three rounds of Delphi panels to reach agreement. The study is led by Ente Ospedaliero Cantonale in Lugano, Switzerland, with Dr. Giorgio Prouse as the principal investigator. There is no direct patient involvement in this study, and while ethics approval was waived, participants’ contributions are voluntary and confidential. If successful, the results could help standardize how PMSGs are used for abdominal aortic aneurysms in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Physicians with no complex endovascular repair experience