ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study

Inclusion criteria

• Patient age ≥ 18 years
• Patient agrees to participate and comply with the protocol by signing an Ethics Committee approved consent form
• Peripheral arterial disease with a documented Rutherford Class 2-5 and

• a resting ankle-brachial index (ABI) of <0.9 or an abnormal exercise ABI (<0.75) if resting ABI is normal. Patient with incompressible arteries (ABI >1.2) must have a toe brachial index (TBI) <0.7 in target limb;
• or a previous intervention to the target vessels with reoccurrence of symptoms
• Balloon resistant calcific lesion apparent on angiogram by inability to dilate lesion to less than 50% diameter stenosis (DS)
• Lesion to include fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending greater than 1 cm in length
• De novo or restenotic lesion of the SFA, popliteal or infrapopliteal artery
• Minimum reference vessel diameter (RVD) of 2.5mm
• Minimum target lesion length of ≥ 5cm
• At least one patent (<50% stenosed) runoff vessel to the foot

Exclusion criteria

• Patient is pregnant or breast feeding (Female subjects of childbearing potential must have negative serum pregnancy test 7 days prior to treatment)
• Life expectancy < 12 months
• Cerebrovascular accident < 60 days prior to procedure
• Myocardial infarction < 60 days prior to procedure
• Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up
• Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure
• Uncontrolled hypercoagulability or history of HIT or HITT syndrome
• Serum creatinine ≥ 2.5 mg/dL tested within a week prior to procedure
• Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint
• Patient is not eligible for bypass surgery or endovascular intervention
• Planned major amputation
• Planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30-day follow-up (including, but not limited to aortic, renal, cardiac, carotid, contralateral femoropopliteal, and contralateral below the knee
• Lesion located within a stent or endograft
• Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis ≥ 50% DS that is not successfully treated prior to index procedure
• Target lesion could not be crossed with the guidewire or support catheter