Spectranetics Corporation is planning to conduct a study to evaluate excimer laser atherectomy using its Turbo-Tandem and Turbo Elite products in patients with femoropopliteal in-stent restenosis.
The study will compare the safety and efficacy of excimer laser atherectomy using these products in conjunction with balloon angioplasty, compared to balloon angioplasty alone, in a 2:1 fashion.
The study will enrol up to 353 patients across 30 sites in the US.
The primary safety endpoint will measure major adverse events defined as death, major target limb amputation and target lesion revascularisation through 30 days following the procedure.
The trial’s primary efficacy endpoint defined as freedom from clinically-driven target lesion revascularisation, will be evaluated at six months following the procedure.
The study results will be used for the 510(k) filing with the US Food and Drug Administration (FDA).
Peripheral arterial disease is a serious cardiovascular condition that causes arteries in the legs to become restricted. Common endovascular procedures for its treatment include laser atherectomy, balloon angioplasty and stenting.
In-stent restenosis is a condition caused the body’s response to the stent implantation, leading to the development of scar tissue extending into the opening of the artery.