Rationale for a new registry on EVAR: The EXTREME study

Area of Science:

• Vascular Surgery
• Medical Device Technology
• Clinical Trial Design

Background:

• Standard endovascular aneurysm repair (EVAR) has limitations in patients with complex aortic anatomies.
• Challenging anatomies often necessitate open surgical repair, which carries higher risks.
• There is a need to explore expanded indications for EVAR in these difficult cases.

Purpose of the Study:

• To present the rationale for a physician-initiated, multi-centric prospective study.
• To evaluate the feasibility and safety of standard EVAR in patients with challenging aortic anatomies.
• To establish the EXTREME (Expanding Indications for Treatment with Standard EVAR in Patients with Challenging Anatomies) trial.

Main Methods:

• Prospective, multi-centric clinical evaluation.
• Inclusion of patients with anatomically challenging criteria for EVAR.
• Standard EVAR device utilization and procedural data collection.

Main Results:

• Study rationale and design are presented.
• Patient selection criteria for challenging anatomies are defined.
• The EXTREME trial protocol is outlined for prospective data collection.

Conclusions:

• The EXTREME study aims to broaden EVAR applicability.
• Evaluating standard EVAR in challenging anatomies may offer less invasive options.
• This research seeks to provide evidence for expanded EVAR indications.