Atherosclerosis of Native Arteries of the Extremities, Unspecified Clinical Trial
Official title:
Stenting of the Superficial Femoral (SFA) and Proximal Popliteal Arteries (PPA) With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System
The primary objective of this clinical study is to determine whether the Innova Stent System shows acceptable performance in long-term (12-month) safety rates and vessel patency when treating femoropopliteal lesions.
Atherosclerosis is a systemic disease that has become increasingly recognized in the
expanding elderly population as a significant cause of morbidity and mortality.
Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms
ranging from intermittent claudication to ischemic rest pain and critical ischemia with
major tissue loss. Typically, femoropopliteal lesions have been difficult to successfully
treat with endovascular therapy because the disease is often diffuse and located in an area
of the body subject to significant mobility stresses such as extension, contraction,
compression, elongation, flexion and torsion.
The SuperNOVA clinical study is a prospective, single arm, controlled, multicenter, global
study. Approximately 50 centers located in the United States, Europe, Canada and/or
Australia are expected to participate in recruiting patients needing treatment of lesions in
their femoropopliteal arteries. A maximum of 300 subjects will be enrolled to ensure that a
minimum of 296 stented segments are treated with the Innova Stent System.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment