Closed to Enrollment

Introduction

Peripheral Artery Disease (P.A.D.) is commonly referred to as hardening of the arteries. In P.A.D., the inside of the artery becomes narrow and blood flow is reduced. P.A.D. affects 8-12 million people in the US and can lead to serious health problems such as stroke, heart attack, or amputation. Early in this disease, common symptoms may include cramping or pain in the legs and heavy or tired legs while exercising or at rest. Only about one third of all people with P.A.D. feel pain; most people with P.A.D. have no symptoms at all. Exercise, medications, balloon angioplasty, bypass grafts, plaque removal devices and stents similar to the one used in this study are used to improve blood flow in the legs. 

The purpose of this study is to evaluate the safety and effectiveness of primary stenting using the PROTEGE^® EverFlex™ Self-Expanding Stent System compared to PTA performance goals for the treatment of stenotic, restenotic or occluded lesions (non-stented) of the native superficial femoral artery or the superficial femoral and proximal popliteal arteries.

Design

• US FDA IDE study
• Pivotal study-prospective, multi-center, non-randomized, single arm
  • 287 subjects
  • Up to 40 US centers and 6 EU centers

Primary Endpoints

• Primary Safety Endpoint: Major Adverse Events at 30 Days
• Primary Effectiveness Endpoint: Primary Patency at 1 Year

Inclusion/Exclusion Criteria

• 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

Follow-up

• Pre-discharge, 30 days, 6 months and 1, 2 and 3 years post procedure

Principal Investigators

Jon Matsumura, MD, University of Wisconsin School of Medicine and Public Health, Milwaukee, WI
Krishna Rocha-Singh, MD Prairie Heart Institute, Springfield, IL

For additional information on this study email: Clinical@ev3.net
Visit: clinicaltrials.gov: Identifier NCT00530712