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

Study Overview
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Brief Summary
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This single center prospective, randomized study will be conducted to investigate plaque removal and luminal gain using CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy System (OAS) (St.Paul, MN) versus Medtronic's Hawkone Directional Atherectomy system (DAS) (Minneapolis, MN) assessed by angiography and Intravascular Ultrasound (IVUS) in patients diagnosed with symptomatic obstructive femoro-popliteal disease will be analyzed. Both devices have received clearance by the Food and Drug Administration (FDA) for use by the label indication.Subjects will be randomized in a 1:1 fashion to receive treatment with either OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB) or DAS (using the Hawkone device) followed by DCB. Subjects in both arms will undergo IVUS before and after atherectomy, as well as at the conclusion of the procedure. Clinical data will be collected at baseline, immediately prior to the procedure, during and immediately after the procedures, and within 30 days, 6 and 12 months office visits after the procedure. Data may also be collected at office or hospital visits that are not scheduled but occur up to 12 months after the procedure, if they pertain to treatment related to the obstructive SFA disease. Data to be collected for this study includes demographics, medical history, procedural parameters and follow-up. The study will be conducted at one study center, 90 subjects will be enrolled in the trial with plan to accrue 60 subjects - 30 patients enrolled in the OAS arm and 30 patients enrolled in the DAS arm. The duration of the study is expected to be approximately 2 years from the date of first enrollment (1 year for enrollment of 60 subjects and a year for follow-up).

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

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS
* Device: Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS)<br>OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB) | Device: Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device<br>* HawkOne Directional Atherectomy System (DAS) also is the small catheter with cutting device. Doctor slowly and smoothly advances it across the blockage in your artery and shaves the plaque from the vessel wall and collects it in the reservoir.<br>|
| Active Comparator: Medtronic's Hawkone Directional Atherectomy system (DAS)<br>DAS (using the Hawkone device) followed by DCB | Device: Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS<br>* Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is a small catheter with a diamond crown. The doctor inserts it at the groin and advances into the leg.The OAS works by spinning around inside the artery to sand down the buildup of material along the artery walls while leaving the healthy vessel behind.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Minimal Luminal Area | To be measured via Intravasular Ultrasound (IVUS) before and after atherectomy | Day 0, Immediately before procedure, immediately after procedure | 
| Change in Percentage Diameter Stenosis (%DS) | Angiographic measurements of diameter stenosis following atherectomy | Day 0, Immediately before and after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percentage Plaque Volume | To be measured and analyzed via Intravascular Ultrasound (IVUS) | Day 0, Immediately before procedure, immediately after procedure |