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Keep this study
Lead
NYU Langone Health
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound
