Peripheral Arterial Disease Clinical Trial
Official title:
Drug Eluting Stent for the Management of PERipheraal Arterial Disease of the SFA (DESPERADO-SFA Study)
This is a prospective, nonrandomized, single-arm study using the Zilver PTXTM stent in patients with Superficial Femoral Artery (SFA) disease (total occlusions or significant stenosis).
Endovascular therapy is widely used for the treatment of peripheral artery disease (PAD).
Primary nitinol stenting for superficial femoral artery (SFA)) lesions has been shown to be
superior to balloon angioplasty alone. Zilver PTX a paclitaxel -eluting nitinol stent has
been approved by the Food and Drug Administration (FDA) for femoro-popliteal artery use.
Previous study have reported safety and effectiveness of the Zilver PTZ in patients with de
novo or re-stenotic lesions of the femoro-popliteal artery.
Optical Coherence tomography (OCT) is a novel intravascular imaging modality with a unique
and fine resolution of 10 µm at the level of a red blood cells providing detailed images of
vascular wall following stent implantation for evaluation of optimal stent apposition and
expansion as well as intraluminal clot.
20 patients with symptomatic critical limb ischemia (CLI) and claudication without CLI
(Rutherford class 2-6) and identifiable SFA disease on angiogram requiring percutaneous
peripheral intervention (PPI)will be enrolled in this study. We would like to study the
vessel apposition and expansion immediately after initial implantation as well as evaluation
of late stent malapposition and neointimal hyperplasia at the 12 months follow up after
Zilver PTXTM stent implantation using intravascular OCT imaging. Follow up visits will take
place at 1 month, 6 month, 12 month and 13 month after the procedure.
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