Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II

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

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

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.

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