This is a quasi-experimental observational, cross-sectional evaluative study that is conducted at the Simulation Center of the Faculty of Medicine of Sfax from September 15, 2024, to June 2026. We are assessing the effectiveness of a training session using an interventional simulator in the learning of invasive procedures (ie, peripheral angioplasty) among beginners in the field.

This is a quasi-experimental, observational, cross-sectional evaluative study. The study was registered with PACTR (TrialID=30697) and received ethical approval from the Ethics Committee of the Faculty of Medicine of Sfax (approval number 49/24).

In this study, all three groups of learners—fellows in Cardiology, Radiology, and Vascular Surgery—are undergoing the same standardized simulation training curriculum.

The study used a “Mentice Brand Simulator,” an interventional simulator with a high-fidelity platform. The system incorporates an advanced hardware configuration, including a control unit enabling adjustment of fluoroscopic projection angles, table movements, and image magnification; a fluoroscopy pedal allowing real-time fluoroscopic activation; an instructor module permitting selection among a wide range of catheters, guidewires, balloons, and stents; and a haptic feedback system that provides realistic tactile sensations during device manipulation. The simulator is supported by an integrated software and display system based on a notebook computer interface that presents detailed procedural and scenario information, real-time fluoroscopy duration, simulated patient hemodynamic parameters (including blood pressure and heart rate), cumulative radiation dose calculations, and anatomically accurate vascular models incorporating realistic lesion morphology and pathological features. In addition, the Mentice VIST-FLEX includes a comprehensive radiation simulation and safety monitoring module, offering realistic dose calculations such as fluoroscopy time and cumulative radiation dose.

Primary outcome is the percentage change in Global Score from pre-test to posttest, calculated as percentage improvement=100×(Final Global Score − Initial Global Score) / Initial Global Score. We will consider that there is a significant improvement in the knowledge and the skills of the learner if the percentage variation is more than 25%. We will also compare scores based on the specialty of the trainee: Cardiology, Radiology, and Vascular Surgery.

As secondary outcomes, we will assess the radioprotection parameters. All radiation protection parameters are automatically recorded by the Mentice simulator for each participant’s each scenario:

We will use SPSS Statistics software (version 21; IBM Corp) to conduct the statistical analysis. We will check the normality of the distribution of variables. Due to the small sample size, we expect that the distribution of our population is non-Gaussian. In this case, we will express all quantitative values as median (with extremes and the semiinterquartile range), and use nonparametric tests, specifically the Wilcoxon test, to compare performance and competence scores before and after the training cycle (paired sample tests). To compare scores between those who have never performed interventional procedures (novices) and those with prior experience, we will use the nonparametric Mann-Whitney U test. We will consider differences to be significant if P<.05.

Study enrollment commenced on September 15, 2024, at the Simulation Center of the Faculty of Medicine of Sfax, Tunisia. The study is planned over 21 months, with completion anticipated in June 2026.

As of December 2025, 42 fellows have been screened. Of these, 21 met the inclusion criteria and were enrolled, while 21 were excluded due to prior catheterization laboratory experience. The current enrollment corresponds to 35% (21/60) of the planned sample size.

All 21 enrolled participants have completed the full five-scenario simulation training protocol, including both pretest and posttest assessments.

Table 2 summarizes the characteristics of enrolled participants by specialty.

Completed milestones include the pilot study (HE Marman, MD, unpublished data, 2024), ethics approval from the Faculty of Medicine of Sfax (approval number 49/24), trainer standardization (August 2024), opening of enrollment (September 15, 2024), and enrollment and training of the first 21 participants.

Ongoing activities as of December 2025 consist of continued recruitment to reach the target sample size of 60 fellows, with focused efforts to increase participation specifically from Interventional Radiology and Vascular Surgery programs.

Planned milestones include completion of enrollment and data collection by June 2026, followed by statistical analysis during June-July 2026, and manuscript preparation and submission to JMIR Research Protocols during July-September 2026.

Based on our methodological approach, this study is anticipated to demonstrate that high-fidelity simulation training significantly improves both knowledge and technical competence in peripheral angioplasty across all three specialty groups. The comparative analysis across specialties will be novel in the simulation training literature and will provide the first evidence specifically addressing whether specialty background influences skill acquisition in peripheral angioplasty simulation training.

Szőnyi et al [14] have recently reviewed the evolution of vascular interventional radiology and endovascular surgery, noting the increasing involvement of multiple specialties in peripheral interventions and the resulting need for standardized training pathways. This study directly addresses the identified need.

This study demonstrates several key strengths, including the use of high-fidelity simulation with comprehensive radiation dosimetry monitoring—unlike previous studies focused primarily on procedural competence—which aligns with current ALARA principles; a standardized curriculum delivered identically across all three specialty groups that eliminates content confounding and isolates specialty-related learning factors; employment of a single experienced trainer throughout to ensure consistent assessment criteria and eliminate instructor variability; a prospective pre-test or post-test design comparing each participant to their own baseline for robust evidence of training effectiveness; a novel multi-specialty comparative design representing the first systematic evaluation of learning outcomes across Cardiology, Radiology, and Vascular surgery fellows in peripheral angioplasty simulation training; comprehensive 25-item Global Score assessment instruments evaluating both knowledge (10 items) and technical competence (15 items); and detailed methodology documentation enabling replication by other simulation centers.

The primary limitations include absence of real-world validation through direct assessment of participant performance in actual catheterization laboratory settings, which limits clinical applicability; current enrollment of 21/60 participants with unequal specialty distribution (particularly only 3 radiology fellows) that constrains statistical power for between-group comparisons; and the single-center design conducted solely at the Faculty of Medicine of Sfax, which may limit generalizability to other geographic regions, health care systems, or simulation centers with different equipment and institutional cultures.

This protocol describes the first comparative study evaluating the impact of high-fidelity simulation training on peripheral angioplasty skill acquisition and performance outcomes across three distinct interventional specialties: cardiology, interventional radiology, and vascular surgery. The study will also provide comprehensive data on radiation protection parameters, contributing to the evidence base for ALARA principle implementation in procedural training. Upon completion, this study will serve as a methodological template for examining specialty-specific learning across diverse interventional procedures and specialties, supporting evidence-based approaches to procedural training and competency assessment in the future.