Atherectomy By Laser Ablation With Turbo-Elite

Atherectomy By Laser Ablation With Turbo-Elite

The primary objective for this study is to prove the safety and effectiveness of the Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50%.

Inclusion Criteria:

• PAD with Rutherford Class 1-4
• Patient is able to walk unassisted or with non-motorized assistive devices.
• Documented PAD by ABI <0.9 or previous intervention with reoccurrence of symptoms
• Documented stenosis by duplex ≥50%

Exclusion Criteria:

• Patient is pregnant or breast feeding.
• Evidence of Acute Limb Ischemia within 7 days prior to procedure.
• CVA < 60 days prior to procedure.
• MI < 60 days prior to procedure.
• Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up.
• Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
• Uncontrolled hypercoagulability or history of HIT or HITTS syndrome.
• Serum creatinine ≥ 2.5 mg/dL (unless dialysis-dependent) within one day prior to procedure.
• Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint.
• Previously identified severe calcium in the vessel.