LB05 - Early Enrollment and Safety Experience from an Ongoing International Multicenter Randomized Trial Evaluating Fiber Optic–Based 3D Navigation During Fenestrated Endovascular Aortic Repair

Saturday, June 13, 2026

8:24 AM - 8:33 AM ET

Location: Hynes CC, Third Level, Ballroom A

Submitting & Presenting Author(s)

Andres Schanzer, MD (he/him/his)

Professor
Division of Vascular and Endovascular Surgery, University of Massachusetts Chan Medical School, Worcester, MA
Worcester, Massachusetts

Co-Author(s)

Adam W. Beck, MD

Professor of Surgery
University of Alabama at Birmingham
Birmingham, Alabama
Darren B. Schneider, MD

Chief of the Division of Vascular Surgery and Endovascular Therapy
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania
Carlos H. Timaran, MD, MS

Professor of Surgery
University of Texas Southwestern Medical Center Dallas
Dallas, Texas
Marc L. Schermerhorn, MD

Chief, Division of Vascular and Endovascular Surgery
Beth Israel Deaconess Medical Center
Boston, Massachusetts
GS

Geert Willem H. Schurink

Maastricht University Medical Center
Maastricht
BM

Bijan Modarai

Professor of Vascular and Endovascular Surgery
Department of Vascular Surgery, Guy’s & St Thomas’ NHS Foundation Trust, London, UK, England, United Kingdom
NM

Nathalie Moreels, MD

Ghent University Hospital, Belgium
Ghent
FC

Frederic Cochennec

Vascular Surgeon
Henri Mondor Hospital
Paris
TR

Tim A. Resch

Department of Vascular Surgery, Rigshospitalet, Copenhagen University Hospital
Copenhagen

Senior Author(s)

TK

Tilo Kölbel, MD, PhD

Vascular Surgeon
German Aortic Center, Department of Vascular Medicine, University Heart and Vascular Center UKE Hamburg
Hamburg, Germany

Objectives: Fenestrated endovascular aortic repair (FEVAR) relies heavily on fluoroscopic imaging, resulting in substantial cumulative radiation exposure for both patients and operators. Fiber optic–based real-time three-dimensional navigation has been developed to reduce fluoroscopy dependence during complex endovascular procedures. However, prospective randomized data evaluating the feasibility and safety of this technology in FEVAR are currently limited. This abstract reports early enrollment and safety experience from an ongoing randomized clinical trial.

Methods: RadFree is a prospective, randomized, international, multicenter clinical trial comparing fiber optic–based three-dimensional navigation with conventional fluoroscopic guidance during FEVAR. Adult patients undergoing primary FEVAR involving at least two target visceral vessels are randomized 1:1. The planned enrollment is 182 patients across 11 sites in the United States and Europe. The primary endpoint is total fluoroscopy time, with secondary endpoints including radiation exposure metrics, procedural efficiency, and device-related adverse events. This late-breaking analysis focuses on enrollment progress, feasibility, and early safety experience.

Results: As of abstract submission, 37 patients have been enrolled across 7 active sites in the United States and Europe, with additional sites progressing through activation. Enrollment has advanced in accordance with projected timelines toward the target sample size. Among the enrolled cohort, mean age was 74 ± 8 years. Twenty-nine patients (78%) were men and 8 (22%) were women. Aneurysm morphology included 30 (81%) juxtarenal/pararenal/type IV thoracoabdominal aneurysms and 7 (19%) type I–III thoracoabdominal aneurysms. Device configurations included 34 (92%) four-fenestration constructs, 2 (5%) three-fenestration constructs, and 1 (3%) two-fenestration construct. No device-related or procedure-related adverse safety events have been observed among enrolled patients to date. Participating investigators successfully incorporated fiber optic navigation into standard FEVAR workflows without early feasibility concerns or protocol deviations. Formal efficacy analyses are planned following completion of enrollment and prespecified interim analysis.

Conclusions: Early experience from the RadFree randomized, international multicenter trial demonstrates successful enrollment, broad site participation, procedural feasibility, and an encouraging early safety profile for fiber optic–based three-dimensional navigation during FEVAR. Ongoing enrollment toward the planned 182-patient cohort will enable rigorous evaluation of whether this technology meaningfully reduces fluoroscopy use and radiation exposure during complex endovascular aortic repair.