The Jetstream G3™ Calcium Study

Exclusion Criteria

• •1. Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent.
• •2. Patient is unable to take appropriate anti-platelet therapy.
• •3. Patient has no distal runoff vessels.
• •4. Deep wall calcium.
• •5. Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
• •6. Patient has target vessel with moderate or severe angulation (e.g., \>30 degrees) or tortuosity at the treatment segment.
• •7. Patient has a history of coagulopathy or hypercoagulable bleeding disorder.
• •8. Patient is receiving hemodialysis or has impaired renal function (creatinine is \> 2.5 mg/dl) at the time of treatment.
• •9. Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
• •10. Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
• •11. Patient is pregnant or nursing a child.
• •12. Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G3 System.
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