Atherosclerosis of the Peripheral Artery Clinical Trial
Official title:
Pilot Prospective Study of Two Methods of Revascularization of the Superficial Femoral Artery: Stenting in the Superficial Femoral Artery, and Stenting of the Superficial Femoral Artery, Supplemented by Fasciotomy in Hunter Channel in Patients With Steno-occlusive Lesions of Femoral-popliteal Segment TASC C, D
Comparison of two methods for revascularization of the superficial femoral artery: stenting of the superficial femoral artery vs. stenting of the superficial femoral artery supplemented with fasciotomy in Hunter canal in patients with steno-occlusive lesion of the femoro-popliteal segment of TASC C, D.
Physiological flexions and extensions in hip and knee joints cause dramatic deformity in
stented femoral and superficial femoral arteries, both axially and angularly. As a result,
stents get broken, restenosed or thrombosed. Some researchers report a 20 to 46% two-year
incidence of broke stents in the superficial femoral artery, while restenosis and occlusion
incidence vary from 21.8% to 53.3% . In addition to axial and angular stress, contributing
to this untoward effect is musculofascial sheath which houses the artery in distal thigh.
Investigators suggest that standard stenting of an artery be augmented by incision of the
anterior musculofascial sheath (septum intermuscular vastoadductoria) that will increase the
mobility of distal part of the femoral artery, which will decrease frequency breakage of
stents. Review of the world literature yielded no peer instances of such improvement of
stenting outcomes in the said arteries.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment