A Prospective, Non-randomized Study to Evaluate the Safety and Performance of the NovaCross™ Microcatheter in Femoropopliteal Chronic Total Occlusion (CTO).

This is an open label, single center, prospective, first in man pilot study in which the investigational device, NitiLoop micro-catheter, will be tested in up to 15 patients with symptomatic peripheral arterial occlusive disease scheduled to undergo CTO in an anterograde approach.

Inclusion criteria

• Adult aged 25-80
• Patient understands and has signed the study informed consent form.
• Patient has symptomatic peripheral artery disease (PAD) requiring endovascular revascularization of a CTO, evidenced by angiography, computed tomography or magnetic resonance angiography.
• Patient has an occluded femoropopliteal or infra popliteal artery
• Target femoropopliteal or infra-popliteal vessel is ≥ 2.5 mm and ≤5 mm in diameter.
• Patient has Rutherford-Becker Classification of 2-5.

Exclusion criteria

• Patient unable to give informed consent.
• Current participation in another study with any investigational drug or device.
• Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
• Patient has a known sensitivity or allergy to anti-platelet medications.
• Patient is pregnant or lactating.
• Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
• 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 had undergone attempted treatment of the CTO within the prior 3 months (to prevent a guidewire from entering dissection planes created by prior recanalization attempts.
• Vasculitis and Buerger disease (thrombendarteritis obliterans)
• Evidence of embolism
• Peripheral vessel aneurysm