First clinical evaluation of a luminal self-expanding shield in patients with intermediate coronary lesions

Earlier generation self-expanding stents (SExS) showed high restenosis rates and long-term stent over-expansion. A novel SExS with reduced outward expansive force has been developed to overcome these limitations. This first-in-human study aimed to evaluate the safety and feasibility of the low pressure self-expanding nitinol-based vProtect™ luminal shield (LS) in the treatment of intermediate coronary lesions.

A total of 29 patients with clinical evidence of myocardial ischaemia and intermediate de novo coronary lesions were included. The LS was deployed after low-pressure balloon pre-dilatation. Acute procedural and device success was achieved in all patients. Angiographic follow-up at nine months showed an in-stent lumen loss of 0.50±0.30 mm and a binary restenosis rate of 10.3%. There were no cases of late LS over-expansion or acute/late malapposition as evaluated by intravascular ultrasound (IVUS). The cumulative major adverse cardiac events (MACE) rate at nine months was 10.3%, consisting of three target lesion revascularisations, with no cases of death, myocardial infarction or stent thrombosis.

Implantation of the LS in non-complex coronary lesions of intermediate severity was feasible, safe, and resulted in low rates of late loss and restenosis. IVUS analysis at nine months showed favourable mechanical properties of the LS without evidence of late device over-expansion.