Prospective, Multi-center, Single-arm Study of the Auryon Laser System for Treatment of Below-the-Knee (BTK) Arteries

Study Overview
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Brief Summary
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The Auryon Laser Atherectomy System has been cleared by the FDA to treat infrainguinal arterial disease including in-stent restenosis

Detailed Description
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To observe the treatment effects of the Auryon Laser Atherectomy System in treating Infrapopliteal peripheral arterial disease

Official Title
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Prospective, Multi-center, Single-arm Study of the Auryon Laser System for Treatment of Below-the-Knee (BTK) Arteries

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Auryon Laser System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Subject is 18 years of age or older. 2. Critical limb ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 4-5 in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure. 3. Patient has signed approved informed consent. 4. Patient is willing to comply with the follow-up evaluations Angiographic Inclusion Criteria Target lesions(s) must be viewed angiographically and have ≥50% stenosis. More than one lesion can be included in the same vessel. Only 1 target vessel is included in the study. Intraluminal crossing of the lesion. If this is not certain, IVUS may be used to verify this per operator's discretion. Target Lesion reference vessel diameter (RVD) between 1.5 mm - 4.5 mm. by investigator estimate. 4. Target lesion is denovo or restenotic. - Exclusion Criteria: Target lesion is in a vessel graft or synthetic graft. Subjects requiring dialysis. Subject is unable to understand the study or has a history of non-compliance with medical advice. Subject is unwilling or unable to sign the Informed Consent Form (ICF) Subject is currently enrolled in another clinical investigational study that might clinically interfere with the current study endpoints. Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for. Subject has a CVA or TIA within 4 weeks prior to the Auryon procedure. Planned Use of another debulking device or specialty balloons before or after the Auryon laser during the index procedure Patient has any planned surgical intervention or endovascular procedure ≤14 days after the index procedure or had these procedures in the past 14 days Life expectancy of less than one year judged by the investigator Patient unable to take anticoagulant or antiplatelet agents Platelet count less than 80,000K or bleeding disorders Subject is suspected of having an active systemic infection. Patient enrolled once already in the protocol Planned major amputation of either leg. Acute limb ischemia Current Covid-19 Infection or history of Covid-19 in the past 30 days. Subject is pregnant or planning on becoming pregnant. Vulnerable patients who are unable to give informed consent on their own Pregnant and Vulnerable Populations. There will be no female patients who are pregnant or any vulnerable populations enrolled in the study. Subject experiencing ongoing cardiac problems that per the investigator judgment would not make the subject ideal per the procedure Subject has evidence of intracranial or gastrointestinal bleeding within the past 3 Angiographic Exclusion Criteria 1. Failure to treat clinically significant inflow lesions in the contralateral iliac, ipsilateral iliac, femoral, or P1-P2 segments of the popliteal arteries with ≤ 30 % residual stenosis, and no serious angiographic complications (e.g., embolism) 2. Failure to successfully treat significant non-target infra-popliteal lesions prior to treatment of the target lesion. Successful treatment is defined as obtaining ≤ 50 % residual stenosis with no serious angiographic complications (e.g., embolism). 3. Failure to successfully cross the guidewire across the target lesion; successful crossing is defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations. 4. In-stent restenosis. -

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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Accepts Healthy Volunteers

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
Interventional Model Description: Prospective, multicenter, single arm study Patients with symptomatic peripheral vascular disease who underwent infrapopliteal percutaneous intervention using the Auryon laser system 4 sites in United States
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auryon Laser Treatment Arm<br>Auryon Laser to be used on target lesion in the below the knee artery. | Device: Auryon Laser System<br>* The Auryon BTK Study is a prospective, single arm multicenter study evaluating the safety and procedural effectiveness of the Auryon laser in treating infrapopliteal disease in patients with critical limb ischemia and claudication. The primary exposure of interest for this study is the use of the AURYON system for atherectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Safety Endpoint: | Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days, as adjudicated by the CEC, defined as a composite of: All-cause death Above-ankle amputation of the index limb Major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a BTK artery | 30 days | 
| The Primary Performance Endpoint: | Procedure Success defined as ≤30% residual stenosis for the treated segment of the vessel without serious angiographic complications (flow-limiting dissection (D to F), perforation, distal embolization, or acute vessel closure after final treatment, as assessed by the angiographic core lab. | Index Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious angiographic complications | flow-limiting dissection (D to F, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab | Index Procedure | 
| Technical success | defined as residual stenosis ≤50% in the target lesion after Auryon laser and prior to adjunctive balloon treatment without significant angiographic complications, as assessed by the angiographic core lab | Index Procedure | 
| Primary patency at 6 and 12 month | s defined as the absence of both total occlusion (100% diameter stenosis by DUS) in all of the target lesions, as well as a Clinically-Driven Target Lesion Revascularization (CD-TLR) (definition in D below). An alternative patency analysis will be done with patency defined as the presence of significant restenosis at the treated site using PSVR of ≤ 2.4 as the threshold for patency and absence of CD-TLR | 6 and 12 months | 
| Clinically Relevant Target Lesion Revascularization | (CD-TLR) at 30 days, 3, 6, and 12 months defined as recurrence of symptoms (worsening by one Rutherford Becker Category from post index procedure) with an objective evidence of obstructive disease (occlusion or PSVR > 2.4 by DUS; or ABI change by 0.15 from post procedure ABI) | 12 months | 
| Major Adverse Events (MAE) | Composite Need for emergency surgical revascularization of target limb Unplanned target limb major amputation (above the ankle) Symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow, and extend hospitalization | 30 days | 
| Perforations | Perforations that require an intervention | Index Procedure | 
| Walking impairment questionnaire | reported as change from baseline | 30 days, 3, 6, and 12 months | 
| EQ-5D-5L Questionnaire | reported as change from baseline | 30 days, 3, 6, and 12 months | 
| Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) | reported as change from baseline | 30 days, 6 and 12 months | 
| Rutherford Category | reported as change from baseline | 30 days, 3, 6, and 12 months | 
| Subgroup analysis stratified by IVUS | Subgroup analysis stratified by IVUS vs non IVUS patients for the primary performance endpoint and the following secondary endpoints: Final Balloon Size used to dilate lesion post laser, CD-target lesion revascularization and clinical patency | Index Procedure | 
| Healed Wounds | Number of healed wounds | 30 days, 3, 6, and 12 months | 
| Mean Lesion Diameter | IVUS subgroup: 20 patients. All will be evaluated for MLA pre and post laser and post final treatment. | Index Procedure | 
| Total Dissections | The presence and number of dissections will be classified based on iDissection classification | Index Procedure |