Post-Market Clinical Follow Up of Rotarex®S Catheter

Exclusion Criteria

• •1. Life expectancy \< 2 years.
• •2. Pregnant or nursing a child.
• •3. Contraindication, intolerance, or allergy to contrast media that, in the opinion of the investigator, cannot be adequately pre-medicated.
• •4. Myocardial infarction within 60 days prior to index procedure.
• •5. History of severe trauma and/or sepsis within 60 days prior to index procedure.
• •6. Cerebrovascular accident (CVA) or Transient Ischemic Attack (TIA) within 60 days prior to index procedure.
• •7. Evidence of intracranial or gastrointestinal bleeding or intracranial aneurysm within 90 days prior to index procedure.
• •8. Abnormal electrocardiogram or blood test results and/or any other factor that would increase risk by participating in the study in the opinion of the investigator.
• •9. Target lesion not crossed with guidewire or extraluminal guidewire crossing (even if in short segments only).
• •10. Additional lesion that is located \>3cm away from the target lesion
• •11. Treatment plan of the target lesion includes laser, brachytherapy, or atherectomy other than the Rotarex®S Catheter.
• •12. Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
• •13. Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics.
• •14. Patients with uncorrected bleeding disorders.
• •15. Thrombophlebitis or deep vein thrombosis within the past 30 days.