AMS INSIGHT 1 Study - Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment

The lesion is pre-dilated with the PLEON EXPLORER balloon with a length of 10 mm or 15 mm or 20 mm under angiographic control. After dilation, the stenosed area is treated by one AMS implant. If the implanted stent is not fully apposed to the vessel wall or if initial angiography reveals a residual stenosis, the stent may be post-dilated with the delivery system balloon. If necessary, a high-pressure, non-compliant balloon catheter may be used.

The lesion is dilated with the PLEON EXPLORER balloon with lengths of 10 mm or 15 mm or 20 mm, respectively. In case that the PTA procedure results in a residual stenosis of \>50%, the AMS implant should be used to improve the result. A flow-limiting dissection does not qualify for stenting. Best effort must be made to obtain a satisfactory result (e.g. multiple and prolonged inflations) before a patient in the PTA group can be treated with a stent.