Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound

This is an interventional treatment trial for Peripheral Artery Disease Read More

Inclusion Criteria:

• Subject's age ≥ 18 years;
• Subject (or Legal Guardian if applicable) is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits.
• Chronic, symptomatic lower limb ischemia defined as Rutherford categories 1-4
• Target lesion(s) located in a superficial femoral or popliteal arteries
• Degree of stenosis ≥70% via Qualitative Comparative Analysis (QCA)
• Total Lesion Length ≥ 80 mm and ≤ 150 mm
• Reference Vessel ≥ 3.0 mm and <6.5mm
• Patent infrapopliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot with no planned intervention.
• Subject is an acceptable candidate for percutaneous intervention using the OAS or DAS in accordance with their labeled indications and instructions for use

Exclusion Criteria:

• Subjects who have an:
• Previously stented target lesion/vessel.
• Subjects who have undergone prior surgery of the SFA/PA in the target limb to treat atherosclerotic disease.
• Presence of aneurysm in the target vessel.
• Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
• Target vessel with moderate or severe angulation (e.g., > 30°) or tortuosity at the treatment segment, that precludes safe advancement of the atherectomy device.
• Pre-planned interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than OAS or DAS.
• Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
• Known hypersensitivity/allergy to antiplatelet, anticoagulant, thrombolytic medications
• Platelet count <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis.
• Patient has any known coagulation disorder, including hypercoagulability
• Receiving dialysis or immunosuppressant therapy.
• Patient has evidence of intracranial or gastrointestinal bleeding within last 3 months.
• Patient has history of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within past 14 days,
• Female patient who is pregnant or nursing a child,
• Current participation in another investigational drug or device clinical study that has not completed the primary endpoint at the time of randomization/enrollment or that clinically interferes with the current study endpoints.