Safety and Effectiveness Study of Eximo's B-Laser™ Atherectomy Device for PAD Treatment

Study Overview
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Brief Summary
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The aim of the study is to assess the safety and efficacy of the use of the Eximo's B-Laser™ catheter in subjects affected with Peripheral Artery Disease (PAD) in lower extremity arteries.

Detailed Description
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This is a prospective, single-arm, multi-center, international, open-label, non-randomized clinical study. All enrolled subjects will undergo atherectomy procedure, during which the B-Laser™ catheter will be used to perform atherectomy in target lesion, followed by any other adjunctive therapy (balloon and/or stent etc.). The procedure will be done according to standard hospital procedure for atherectomy. The steps of the operation before and after the operating of the B-Laser™ device are routinely used practice and will be done according to local practice at each hospital. For the post-atherectomy stage, as an adjunctive therapy in the procedure, any approved device may be used (balloon and/or stent etc.). Subjects will then be followed for 12 months after the procedure.

Official Title
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Safety and Effectiveness Evaluation of Eximo's B-Laser™ Atherectomy Device, in Subjects Affected With PAD

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: B-Laser™ Atherectomy Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years old. Subject is a candidate for endovascular intervention for peripheral artery disease in the lower extremities. Documented symptomatic atherosclerotic peripheral artery disease Rutherford Classification 2-4. Subject has infrainguinal target lesion(s) with any type of stenosis (naïve or recurrent) estimated to be ≥70% based on CT angiogram or other imaging modality. At least one patent tibial run-off vessel at baseline. Subject is capable and willing to comply with the scheduled follow up. Subject is able and willing to sign a written informed consent form (ICF). Intraoperative inclusion criteria (by fluoroscopy angiogram): Reference vessel lumen diameter proximal to target lesion is ≥150% of the outer diameter of the B-Laser™ to be used. Target lesion has been crossed with a guidewire within the true lumen. Target lesion has a stenosis estimated to be ≥70%. Exclusion Criteria: Target lesion is in a vessel graft or synthetic graft. Target lesion length >25 cm. Endovascular or surgical procedure performed less than or equal to 30 days prior to the index procedure OR Planned endovascular or surgical procedure 30 days after the index procedure. Intent to use other atherectomy device in the same procedure. Flow limiting dissection proximal to, distal to or in the target lesion. Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months. Evidence or history of aneurysm in the target vessel within the past 2 months. History of bleeding diathesis, coagulopathy or inability to accept blood transfusions. History of heparin-induced thrombocytopenia (HIT). Significant acute or chronic kidney disease with a creatinine level >2.5 mg/dl, and/or requiring dialysis. Any thrombolytic therapy within 2 weeks of the index procedure. History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated. Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated. Serious illness that may affect subject compliance to protocol and at a minimum the 30-day follow-up. Participating in other clinical study that involves any kind of intervention, including pharmaceutical. Issue that in the judgment of the investigator, may affect the results of the study. Subject is pregnant or planning to become pregnant during the study period. Intraoperative exclusion criteria (by fluoroscopy angiogram): Total occlusion of the Target lesion that cannot be crossed in the true lumen by 0.014 GW. Target lesion length >25 cm. Reference vessel lumen diameter proximal to target lesion is <150% of the outer diameter of the B-Laser™. Any clinical and/or angiographic complication attributed to the use of another device prior to the study procedure. Flow limiting dissection proximal, distal or in the target lesion.

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 |
| --- | --- |
| Experimental: B-Laser™ Atherectomy Catheter<br>Percutaneous Transluminal Angioplasty (PTA) for treatment of infrainguinal arteries in patients with Peripheral Artery Disease (PAD), that the atherectomy part of the PTA will include an experimental atherectomy catheter, B-Laser™. | Device: B-Laser™ Atherectomy Catheter<br>* Laser atherectomy catheter based on 355 nm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With 30 Day Freedom From Major Adverse Events | Need for emergency surgical revascularization of the target limb Unplanned target limb amputation above the ankle Clinically driven Target Lesion Revascularization (TLR) Cardiovascular related deaths | 30 days post procedure | 
| Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (1) | (*NOTE: Device- or procedure-related AE refers only to the ATHERECTOMY PROCEDURE (with B-Laser™) and not the entire index procedure.) Clinically Significant Perforations requiring intervention Clinically Significant Dissections requiring intervention Clinically Significant Embolus requiring intervention Clinically Pseudo-aneurysm requiring intervention | Perioperative (until discharge), an average of 6 days | 
| Number of Lesions With Technical Success Rate: the Ability of the B-Laser™ Catheter to Cross the Target Lesion Stenosis Over the Wire. | The technical success will be evaluated visually by the performing physician during procedure by fluoroscopy. It is evaluated per lesion and not per subject | Intraoperative (during the index procedure, after B-Laser™ catheter crossing, before adjunctive therapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (2) | (*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.) Emboli, defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator Flow limiting dissection | Perioperative (until discharge), an average of 6 days | 
| Number of Participants With 30 Day Freedom From Device/Procedure* Related Adverse Events | (*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.) Clinically Significant Dissections requiring intervention Clinically Significant Embolus requiring intervention Clinically Pseudo-aneurysm requiring intervention | 30 days post procedure | 
| Number of Lesions With Post-intervention Residual Diameter Stenosis of <30% With Adjunctive Therapy Assessed by Fluoroscopic Angiography in Cases Where Adjunctive Therapy is Medically Applicable | The ability of the B-Laser™ catheter to achieve a post-intervention residual diameter stenosis of <30% with adjunctive therapy assessed by fluoroscopic angiography in cases where adjunctive therapy is medically applicable | Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent) | 
| Change in Ankle-Brachial Index (ABI) Post B-Laser™ Device Procedure Compared to Baseline | Change in Ankle-Brachial Index (ABI) post B-Laser™ device procedure compared to baseline. ABI is calculated as the ratio of the ankle blood pressure to the arm blood pressure. The normal value ranges between 0.9 to 1.3. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher ABI score at the later time point represents an improvement through time and vice versa. | baseline and 30 days, 6 months and 12 months post procedure | 
| Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline | Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline. Rutherford Classification has seven stages, from Stage 0 to Stage 6, when the lower value indicate a better outcome: 0= Asymptomatic; 1= Mild claudication; 2= Moderate claudication; 3= Severe claudication; 4= Rest pain; 5= Ischemic ulceration not exceeding ulcer of the digits of the foot; 6= Severe ischemic ulcers or frank gangrene. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent decrease while negative results represent increases, so lower Rutherford score at the later time point represents an improvement through time and vice versa. | baseline and 30 days, 6 months and 12 months post procedure | 
| Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline | Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline. WIQ score ranges from 0-100 with higher score indicating a better walking outcomes. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher WIQ score at the later time point represents an improvement through time and vice versa. | baseline and 30 days, 6 months and 12 months post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PVD, Peripheral Arterial Disease, Peripheral Artery Disease, PAD, Atherosclerosis, Arterial Occlusive Diseases, Peripheral Vascular Diseases