Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration During Lower Extremity Tibial Interventions

Inclusion Criteria:

1. Subject is at least 18 years of age

2. Subject or authorized representative has signed a written Informed Consent

3. Subject is willing to comply with the protocol requirements

4. Rutherford classification 4-6

5. Planned intervention of the native infrapopliteal arteries using balloonangioplasty, atherectomy, and endovascular procedures.

6. Reference vessel diameter for intended location of the distal tip funnel deploymentfor the Protexus catheter is ≥3.5mm and ≤6.0mm by visual estimate

7. Inflow arteries have ≤30% stenosis. Inflow arteries can be treated at the time ofthe study procedure to achieve ≤30% stenosis

Exclusion Criteria:

1. Prior intervention within 30 days of treatment in the planned deployment site forthe Protexus catheter

2. Presence of a stent in the planned deployment site for the Protexus catheter

3. Has perforation, dissection, or other injury of the access vessel or Protexuscatheter deployment site requiring additional stenting or surgical interventionbefore enrollment

4. History of bleeding diathesis or coagulopathy and unable to receive standardanticoagulation during the index procedure

5. Acute limb ischemia defined as onset of symptoms within two weeks of the plannedintervention

6. Inflow arteries have >30% stenosis after treatment at the time of the studyprocedure

7. Pregnant female subject or subject that has a positive pregnancy test within theprevious 7 days

8. Known hypersensitivity or allergy to nitinol

9. Target blood vessels are infected, have extreme tortuosity, or are occluded withcalcified material