Peripheral Vascular Diseases Clinical Trial
Official title:
Non-Randomized, Prospective, Multi-center Evaluation of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System for Occluded or Stenotic Superficial Femoral or Proximal Popliteal Arteries
The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.
The treatment of stenosis in superficial femoral arteries and/or proximal popliteal arteries
with stenting is associated with high restenosis rates, especially with the first generation
stents (stainless steel). Currently, self-expandable nitinol stents are commercialized which
lead to higher primary patency rates as compared to the first generation stents, even in
longer lesions. However, until now most data available are retrospective and uni-center. The
ASSESS study is a prospective multi-center study investigating the performance (restenosis
rate, patency rates) of the ABSOLUTE™. 035 peripheral self-expandable stent in longer
lesions (lesion length from 4.00 mm to 200.00 mm).
Moreover, literature shows stent fracture in nitinol stents, with a possible clinical
relationship. For this reason, the ASSESS study will analyze the stent fractures of the
ABSOLUTE™ stent, and a possible relationship between stent fracture and restenosis.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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