NCT03495453.

Study name	Directional versus orbital atherectomy plaque modification and luminal area assessment of the femoropopliteal artery via intravascular ultrasound
Methods	Prospective, open, randomised, parallel assignment, single‐centre study
Participants	Estimated enrolment: 60 participants Inclusion criteria: age ≥ 18 years; 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 ischaemia 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 < 6.5 mm; 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; acceptable candidate for percutaneous intervention using the OAS or DAS in accordance with their labeled indications and instructions for use. Exclusion criteria: People who have: a previously stented target lesion/vessel; 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; any known coagulation disorder, including hypercoagulability; receiving dialysis or immunosuppressant therapy; evidence of intracranial or gastrointestinal bleeding within last 3 months; 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 randomisation/enrolment or that clinically interferes with the current study endpoints.
Interventions	Arm Intervention/treatment Active comparator: CSI's DIAMONDBACK 360 Peripheral OAS OAS (using CSI device) followed by Inpact Admiral DCB Device: percutaneous revascularisation of the femoropopliteal arteries using an OAS device HawkOne DAS is a small catheter with cutting device. The doctor slowly and smoothly advances it across the blockage in the artery and shaves the plaque from the vessel wall and collects it in the reservoir. Active Comparator: Medtronic's Hawkone DAS DAS (using the Hawkone device) followed by DCB Device: percutaneous revascularisation of the femoropopliteal arteries using a DAS Diamondback 360 Peripheral 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.
Outcomes	Primary outcome measure: Measure of luminal area measured via IVUS at pretreatment and postatherectomy (12 months). All participants will undergo IVUS at pretreatment run to assess the severity and morphology of the plaque composition and postatherectomy run to assess changes postatherectomy treatment. Secondary outcome measure: Plaque burden reduction (12 months): the amount of removed plaque will be analysed via IVUS pretreatment and postatherectomy.
Starting date	12 April 2018
Contact information	Zulfiya Bakirova
Notes

ABI: ankle brachial index

CFA: common femoral artery

CT: computed tomography

CTA: computed tomography angiogram

CLI: critical limb ischaemia

DAS: directional atherectomy system

DCB: drug coated balloon

DUS: duplex ultrasound

DVT: deep vein thrombosis

EQ‐5D: EuroQoL Quality of Life Questionnaire

IFU: instructions for use

IVUS: intravascular ultrasound

LLL: late lumen loss

MAE: major adverse event

OA: orbital atherectomy

OAS: orbital atherectomy system

PA: popliteal artery

PAD; peripheral arterial disease

POBA: plain old balloon angioplasty

PTA: percutaneous transluminal angioplasty

PVR: peak velocity ratio

QoL: quality of life

QVA: quantitative vascular angiography

RCT: randomised controlled trial

SFA: superficial femoral artery

TASC: Trans‐Atlantic Inter‐Society Consensus Document on Management of Peripheral Arterial Disease

TLR: target lesion revascularisation

TBI: toe brachial index