The Jetstream (JET) Post-market Registry

Exclusion Criteria

• •Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent.
• •Patient is unable to take appropriate anti-platelet therapy.
• •Patient has no patent distal runoff vessels.
• •Patient has critical limb ischemia (i.e., Rutherford class 4-6)
• •Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).
• •Interventional treatment is intended for in-stent restenosis.
• •Patient has target vessel with moderate or severe angulation (e.g., \>30 degrees) or tortuosity at the treatment segment.
• •Patient has a history of coagulopathy or hypercoagulable bleeding disorder.
• •Patient is receiving hemodialysis or has significantly impaired renal function (creatinine is \> 2.5 mg/dl) at the time of treatment.
• •Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
• •Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
• •Patient has had surgical or endovascular procedure in the same vascular territory within 30 days prior to the index procedure.
• •Patient has any planned surgical intervention or endovascular procedure within 30 days after the index procedure.
• •Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System will exclude the patient.