iVascular has announced the one-year results from the BARISTA trial, the first clinical trial with Restorer bare metal stent evaluating its safety and efficacy in the treatment of iliac artery lesions. The study provides evidence supporting the performance of Restorer across a broad spectrum of lesion complexity, from TASC A to TASC D.
The BARISTA trial, led by Lieven Maene (Onze Lieve Vrouw, Aalst, Belgium), enrolled 200 patients with all types of iliac lesions. Significantly, 34% of the study population presented with TASC C and D lesions, representing more complex anatomical scenarios and underscoring the robustness of the clinical evaluation.
At one-year follow-up, the trial demonstrated positive clinical outcomes:
- Freedom from target lesion revascularisation (fTLR): 96.4%
- Freedom from restenosis: 94.1%
These results highlight the durability of the Restorer in maintaining vessel patency and reducing the need for intervention.
Subgroup analysis further showed no statistically significant differences in outcomes between patients with TASC A and B lesions and those with TASC C and D lesions. Procedural success was also supported by strong angiographic outcomes, with 98.5% of cases achieving residual stenosis below 30% following the intervention.
“The one-year results of the BARISTA trial confirm that the use of a bare metal stent in iliac lesions remains a safe and effective treatment option, even in more complex lesions,” commented Maene. “The consistency of outcomes across TASC subgroups is particularly encouraging and demonstrates the reliability of this treatment approach.”
Overall, the BARISTA trial reinforces the role of bare metal stenting as a proven and durable strategy in iliac interventions. The results position Restorer as a dependable solution for physicians seeking predictable clinical performance across a wide range of lesion types.
