CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy of the CLiRpath® Photoablation Atherectomy System consisting of the Bias Sheath guiding catheter, in combination with the available CLiRpath® Excimer Laser Catheters ≤ 2.0 mm, to create larger lumens for treatment within the superficial femoral and popliteal arteries above the knee.

Official Title
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CLiRpath® Excimer Laser System to Enlarge Lumen Openings

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: CLiRpath Photoablation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion Criteria Peripheral vascular disease Rutherford Classification 1, 2, or 3; Eligible for revascularization of native vessel (PTA or bypass); Willing and able to comply with the specified evaluations during hospitalization and all required follow-up examinations; Written informed consent given before execution of study procedures; and Age > 18 and ≤ 85 years. Angiographic Inclusion Criteria Reference vessel diameter >/= 4.0 mm and ≤ 7.0 mm as determined by physician visual angiographic assessment of the most normally appearing vessel segment within 10 mm proximal AND 10 mm distal to the target segment. Stenosis within the SFA and/or popliteal artery above the knee of >/= 70% and </= 100% DS (occlusion), as determined by visual angiographic assessment by the investigator at the time of the procedure and documented by angiography in at least two (2) orthogonal views. At least 1.0 cm of visible SFA stump beyond the origin of the profunda artery. Total lesion length >/= 1.0 cm and ≤ 15.0 cm as determined by visual angiographic assessment at the time of the procedure, separate multiple lesions can be combined as two separate treatment areas as long as the sum total of all lesion lengths and/or treatment areas does not exceed 1.0 cm to 15.0 cm. Patency (< 50% DS) of at least one (1) infrapopliteal artery in continuity with the native femoropopliteal artery. - Exclusion Criteria: General Exclusion Criteria Contraindication to intravenous contrast material, heparin, aspirin or other medications required for a percutaneous interventional procedure; Known bleeding or hyper-coagulation disorder; Serum creatinine > 2.0 mg/dL; Uncompensated congestive heart failure; Current enrollment in any investigational study wherein patient participation has not been completed; Prior enrollment in this study; Suspected or confirmed pregnancy; Any patient, who in the opinion of the investigator, would not be a good candidate for enrollment; Myocardial infarction within 60 days; and CVA/TIA within 60 days. Angiographic Exclusion Criteria 1. Subintimal guidewire placement following pilot channel creation through a stenosis or occlusion with any excimer laser catheter, as visualized with IVUS; Calcification likely to prevent the passage of the excimer laser catheter or CLiRpath® Photoablation Atherectomy system; Ipsilateral and/or contralateral iliac stenosis >/= 50% DS that is not treated prior to enrollment in this study; Ipsilateral and/or contralateral iliac treatment of a stenosis prior to enrollment with final residual stenosis >/= 30%, as determined in at least two (2) orthogonal views and documented by angiography; Iliac treatment prior to enrollment where a perforation occurred requiring a covered stent, blood transfusion, or surgery for treatment of the perforation; Identification of any lesion above the knee and/or below the knee in the treated leg (ipsilateral) that will require preplanned or predicted treatment within six (6) months after enrollment and prior to the completion of the six (6) month follow-up, including the iliac artery, the common femoral artery, the peroneal, anterior tibial, or posterior tibial arteries, or any area from the iliacs to the foot outside of the treatment area; Lesions proximal and distal to the treatment site that are >/= 50% DS at time of enrollment; Contralateral leg disease that requires treatment within the next 30 days and prior to completion of the 30 day follow-up; Cardiovascular surgical or cardiovascular interventional procedures (including, but not limited to, aortic, renal, cardiac, carotid, femoro-popliteal, and below the knee) within 30 days prior to enrollment in this study; Planned or predicted cardiovascular surgical or interventional procedures outside of the ipsilateral leg (including, but not limited to aortic, renal, cardiac, carotid, contralateral femoro-popliteal, and contralateral below the knee) within 30 days after entry into this study, and prior to completion of the 30-day follow-up; and Perforation or dissection of grade C or greater seen during or after the creation of the pilot channel.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Treatment<br>CLiRpath Photoablation Atherectomy System | Device: CLiRpath Photoablation System<br>* Use of CLiRpath Laser Catheter to improve vessel lumen diameter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laser Success | The primary efficacy endpoint is laser success, defined as achieving >/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment. | Measured at time of procedure | 
| Major Adverse Events | The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death. | From discharge through the 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Acute procedural success, defined as achievement of </= 30% final residual stenosis, as visually assessed by angiography after all adjunctive treatment(s) deemed necessary by the treating physician. Measures % of patients who achieved a final residual stenosis of </=30%. | measured at time of procedure | 
| Minimum and Maximum Lumen Diameters | Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS). | measured at time of procedure | 
| Clinical Success | Clinical success, defined as primary patency (≤ 50% stenosis at the treatment site), as assessed by duplex Doppler ultrasound at 30 days, six (6) months and 12 months post-procedure | measured post discharge thorugh 12 Months follow-up | 
| Assisted Primary Patency | Incidence of freedom from assisted primary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a stenosis (patent vessel) at the treatment site to prevent reocclusion | Through 12 Months | 
| Assisted Secondary Patency | Incidence of freedom from assisted secondary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site | Through 12 Month | 
| Patients With >50% Stenosis Measured by Duplex Ultrasound | Percentage of patients with >50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure). | Through 12 Month | 
| Rutherford Classification | Rutherford Classification at 30 days, six (6) and 12 months post-procedure. Physician assessed based on ankle pressures and treadmill testing. Rutherford scale: 0=best, 6=worst | Through 12 Months | 
| Adverse Events | Adverse events during procedure and prior to release from the hospital, at 30 days, six (6) months, and 12 months post-procedure. | Through 12 Months | 
| Volumetric Plaque Reduction | Volumetric plaque reduction immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by IVUS. Actual volume of plaque present is presented for each measurement point. | measured at time of procedure |