Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II

Study Overview
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Brief Summary
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Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.

Detailed Description
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The purpose of this clinical study is to evaluate the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing chronic total occlusions (CTOs) in femoropopliteal arteries. The Ocelot Catheter is a minimally invasive percutaneous device that is designed to traverse arterial occlusions through the use of spiral wedges contained in the distal tip of the device. The device is also equipped with an OCT (optical coherence tomography) imaging fiber that provides directional orientation and an intravascular view of the vessel wall and target lesion. The Ocelot Catheter is used in conjunction with standard endovascular devices and as an adjunct to fluoroscopic guidance.

Official Title
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A Non-randomized Study of the Avinger Ocelot System Used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries

Conditions
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Total Atherosclerotic Occlusion of Femoral Artery

Intervention / Treatment
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* Device: CTO crossing in femoropopliteal arteries CONNECT II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is willing and able to provide informed consent Patient is willing and able to comply with the study protocol Patient is > 18 years old Patient has peripheral arterial disease requiring revascularization as evidenced by CTA, MRA or angiography Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate Target vessel is ≥ 3.0 mm in diameter Patient has Rutherford Classification of 2-5 Lesion is recalcitrant to guidewire crossing Exclusion Criteria: Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated Patient has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications Patient is pregnant or lactating Patient has a co-existing disease or medical condition contraindicating percutaneous intervention Target vessel is severely calcified as evidenced by angiography Target lesion is in a bypass graft Target lesion is in a stent (i.e., in-stent restenosis) Patient has had a procedure on the target limb within 7 days Patient has had a procedure on the target limb within the past 30 days and is unstable Patient has a planned surgical or interventional procedure within 30 days after the study procedure Patient is simultaneously participating in an investigational device study for treatment of peripheral vascular disease Patient has a planned amputation of the target limb Patient has a history of bleeding diathesis, coagulopathy or will refuse blood transfusion in cases of emergency

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: Ocelot System<br>CTO crossing in femoropopliteal arteries using the Ocelot System | Device: CTO crossing in femoropopliteal arteries CONNECT II<br>* CTO crossing in femoropopliteal arteries using the Ocelot System<br>* Other names: CONNECT II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | No evidence of in-hospital MAEs, 30 day MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Ocelot System CTO crossing confirmed by angiography. | Day 30 | 
| Primary Efficacy Endpoint | Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Successful delivery, crossing and retrieval of the investigational device in the absence of in-hospital MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections. | Day 0 | 
| Technical Success | Successful delivery, crossing and retrieval of the investigational device without the use of an assist device. | Day 0 | 
| Device Performance | Device performance as assessed by Investigator's input by evaluating both performance of the device and quality of the OCT image as it relates to the ability to identify layered and non-layered structures and the ability of the directional marker bands to aid in orientation of the catheter while advancing through the CTO. | Day 0 | 
| Procedural Time | Total time of the procedure from the insertion of the catheter to its removal following treatment of the CTO | Day 0 | 
| Fluoroscopic Time | Total time fluoroscopy was used during the procedure. | Day 0 | 
| CTO Crossing Time | Time required to cross the CTO during the procedure. | Day 0 | 
| Use of Assist Devices | Comparison of the crossing times for the Ocelot System alone versus the Ocelot System with assist devices. | Day 0 | 
| Contrast/Flush Volumes | Contrast and flush volumes are presented | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Total Occlusion, Optimal Coherence Tomography, Lumivascular