Feasibility,Efficacy,and Safety of Transradial Treatment of Aorto-iliac Lesions With a New 5F Platform: A Single-Center,All-comers,Registry

Abstract

Background:

Transradial arterial access (TRA) using 5 French (5F) devices is a new option to manage percutaneous aorto-iliac interventions, potentially reducing the rate of vascular complications and the length of hospital stay. However, evidence is limited on the efficacy and safety of this approach. The aim of our study was to assess the feasibility, efficacy and safety of TRA 5F approach, using Micro device portfolio by Qualimed, for the treatment of aorto-iliac artery lesions up to 12-month follow-up.

Methods:

This is a single-center, all-comers, observational registry in which 60 consecutive patients undergoing transradial angioplasty due to aorto-iliac steno-occlusive disease were prospectively enrolled from April 2022 to September 2024. We assessed: procedural success of angioplasty using at least 1 TRA (primary efficacy outcome); primary patency at 12 months; length of hospital stay (secondary efficacy outcomes); freedom from major adverse events (MAEs) (primary safety outcome); and freedom from access-related vascular complications (secondary safety outcome).

Results:

Procedural success of aorto-iliac angioplasty using at least one 5F transradial access was achieved in 58 of 60 patients (96.7%). In 66.7% of the cases, an additional transfemoral approach was required, whereas in 2 of 60 patients an unplanned switch from radial to femoral access occurred. Primary patency was 95.0%, since 3 patients underwent target vessel revascularization due to restenosis/thrombosis. Mean hospital stay was 2 days. As for safety, no MAEs were reported. Freedom from (radial) access-related vascular complications was 100% during index hospital stay and 88.3% after12-month follow-up, since 7 radial occlusions occurred.

Conclusions:

These 12-month findings suggest mid-term efficacy and safety of transradial aorto-iliac artery interventions using 5F Micro devices by Qualimed, even in the setting of complex lesions (ie, TASC II classification ≥ C). Larger cohorts and randomized controlled trials will be needed to confirm these results.

Clinical Impact

The study suggests that 5F transradial access for aorto-iliac interventions is a feasible and safe alternative to the traditional femoral approach. The high procedural success, absence of major adverse events, and short hospital stay support its integration into routine practice. For clinicians, this technique may reduce access-site complications and facilitate faster patient mobilization without compromising technical outcomes. The main innovation lies in the availability of a complete 5F device platform, enabling treatment of complex lesions previously unsuitable for radial access. If confirmed in larger studies, this approach may shift practice toward safer, minimally invasive endovascular strategies.