The Jetstream (JET) Post-market Registry
Condition: Peripheral Arterial Diseases
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Intervention: Jetstream Atherectomy System
Intervention description: Atherectomy
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PAD; peripheral artery disease; atherectomy

Summary:

      The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on
      various lesions types/morphologies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is ≥ 18 years of age.

          -  The target de novo or restenotic Percutaneous Transluminal Angioplasty (PTA) lesion(s)
             is/are located in the common femoral, superficial femoral or popliteal arteries.

          -  The reference vessel lumen (proximal to target lesion) is ≥ 4.0mm.

          -  Evidence of ≥ 70% stenosis or occlusion confirmed by angiography.

          -  Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course
             before the patient is considered as entered into the study.

          -  Patient is an acceptable candidate for percutaneous intervention using the Jetstream
             NAVITUS System in accordance with its labeled indications and instructions for use.

          -  Lesion length ≥ 4cm.

          -  Patient has a Rutherford category score of 1-3.

          -  Patient has signed approved informed consent.

          -  Patient is willing to comply with the follow-up evaluations at specified times.

        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.