Skip to content

Secondary Search Options:

  • Add This

Definitive CA

Introduction

Peripheral Arterial 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, stents and plaque removal devices 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 short-term (30 day) safety and effectiveness using the SilverHawk® LS-C (RockHawk) and TurboHawk™ Plaque Excision Systems and SpiderFX® Embolic Protection Device for endovascular treatment of moderate to severely calcified lesions in femoropopliteal arteries.

Design

  • US FDA IDE study
  • Prospective, multi-center, non-randomized
    • 133 subjects
    • Up to 20 clinical sites in the US

Primary Endpoints

  • Primary Safety Endpoint: Major Adverse Event (MAE) Free Rate at 30 days
  • Primary Effective Endpoint: Less than or equal to 50% residual diameter stenosis following atherectomy remaining at the target lesion(s)

Inclusion/Exclusion Criteria

  • Inclusion Criteria:
    • Provides written informed consent
    • Willing to comply with follow-up evaluations at specified times
    • Has leg pain due to peripheral arterial disease
    • Disease located within the femoropopliteal artery
    • Moderate to severe calcification
  • Exclusion Criteria:
    • Previously implanted stent(s) or stent graft(s) in target lesion
    • Life expectancy less than 12 months
    • Has any planned surgical or endovascular intervention of target limb 30 days before or after index procedure

Follow-up Schedule

Pre-procedure, pre-discharge & 30 days

Principal Investigators

Daniel Clair, MD, The Cleveland Clinic, Cleveland, OH
David K Roberts, MD, Sutter Medical Center, Sacramento, CA

For additional information on this study email: Clinical@ev3.net or
Visit: clinicaltrials.gov : Identifier NCT00733135