The Chocolate Touch Study

Exclusion Criteria

• •General:
• •1. Acute limb ischemia, or patient indicated for thrombolytic therapy
• •2. Planned surgical or interventional procedures within 30 days after study procedure.
• •3. Non-target lesion concurrent interventions involving a re-entry device, atherectomy, laser, or ablation procedures, the use of a drug eluting stent, or, treatment with any other drug coated balloon.
• •4. Myocardial infarction or stroke within 30 days prior to the procedure
• •5. Known intolerance to required medications, contrast media that cannot be adequately premedicated, nitinol, or Paclitaxel
• •6. Known impaired Renal Function that could have an impact on contrast tolerance with GFR ≤ 30 ml/min per 1.73 m2 and/or elevated serum creatinine \>2.5mg/dL (220µmol/L) or on dialysis.
• •7. Known bleeding disorder, or on dialysis, or uncontrolled hypercoagulable disorder
• •8. Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease)
• •9. Female who is pregnant or intends to be pregnant during study
• •10. Patient is enrolled in another investigational clinical study or was previously enrolled in this study
• •Angiographic:
• •11. Presence of perforation, dissection (Type D or worse) or other injury in target vessel at time of enrollment
• •12. Severe Calcification at the target lesion (defined as angiographic evidence of dense calcification present on both sides of the vessel wall on two orthogonal views and that extends \>50 continuous mm in length).
• •13. Previous bypass graft, stent at target vessel (must be greater than 20mm from target lesion), or iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath (Note: In-stent restenosis is not allowed.)