Superficial Femoral Artery Stenosis Clinical Trial
Official title:
Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent With Delivery System -The SUMMIT Registry
The intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in
patients with superficial femoral/ popliteal artery disease.
100 patients with symptomatic femoropopliteal artery lesion will be enrolled in the study
and shall undergo 4 visits during the trial -a pre-procedure visit, procedure visit at which
time the stent will be placed, and follow-up visits at 6 and 12 months.
Study hypothesis: The EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System will
be efficacious in patients with Superficial Femoro/Popliteal Artery disease.
The SUMMIT Registry addresses the treatment of peripheral arterial disease (PAD).
PAD represents a major challenge to physicians in treating the Superficial Femoral (SFA) and
Popliteal arteries. These vessels are exposed to enormous mechanical stress what represents
a harsh environment for any endovascular device. During flexing of the knee, the
SFA/Popliteal arteries can bend, rotate, elongate and compress dramatically. An ideal stent
designed for use in the SFA/Popliteal arteries would offer great ranges of movement while
adequately supporting the arteries.
Subject of study is the EPIC™ Femoropopliteal Self-Expanding Stent System which provides a
great range of motions for a highly flexible femoral artery while adequately supporting the
vessel.
Primary objective is to evaluate the efficacy of the device in treating lesions of the
SFA/Popliteal artery.
The project is a multi-centre open label study. Primary efficacy parameter will be assessed
by measuring the in-stent binary stenosis using duplex ultrasound at 6 and 12 months after
the stent placement. Binary restenosis is defined as a peak systolic velocity ratio (PSVR)
≥2.5:1.
Anticipated study duration is 18 months: 6 months recruiting and 12 months follow-up.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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