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

Study Overview
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Brief Summary
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The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes using a new calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes. The MODIFY Pilot study will evaluate safety and performance measurements.

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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Laser induced pressure wave calcium modification


Participation Criteria
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Eligibility Criteria
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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

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br> | Device: Laser induced pressure wave calcium modification<br>* A calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes<br>* Other names: Laser atherectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary performance defined as minimum lumen diameter measured pre-laser atherectomy and post-calcium modification as well as the ability to dilate a previously balloon resistant lesion after calcium modification procedure | Minimum Lumen Diameter (MLD) measured pre-laser atherectomy and post-calcium modification, as measured by angiography and QVA. The ability to dilate a previously balloon resistant lesion after calcium modification procedure with low pressure balloon inflation. | Index procedure | 
| Primary safety as defined as major adverse event (MAE) composite of all cause death, target vessel revascularization and major amputation of the target limb. | Safety outcome through 30-day follow-up (MAE composite): All cause death Target vessel revascularization (TVR) Major amputation of target limb | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral arterial disease, calcium