Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2013-07-31

Brief Summary

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This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.

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Detailed Description

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Conditions

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Peripheral Vascular Diseases Claudication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PTA and Stenting with EverFlex device

Qualified subjects undergo treatment of atherosclerotic lesions in the native SFA/SFA/PPA with PTA and stenting using the PROTÉGÉ® EverFlex™ Self-Expanding Stent System

Group Type EXPERIMENTAL

PROTÉGÉ® EverFlex™ Self-Expanding Stent System

Intervention Type DEVICE

Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.

Interventions

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PROTÉGÉ® EverFlex™ Self-Expanding Stent System

Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts) or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries.
* Symptomatic femoral-popliteal atherosclerosis.
* Willing to comply with all follow-up evaluations at the specified times.
* Provides written informed consent prior to enrollment in the study.

Exclusion Criteria

* Previously implanted stent(s) or stent graft(s) in the target vessel.
* Planned use of devices other than angioplasty balloons during procedure.
* Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure.
* Life expectancy of less than 12 months.
* Symptomatic femoral disease in the opposite limb.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No