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

Study Overview
=================
Brief Summary
-----------------
Trial is to evaluate the safety and performance of the NovaCross™micro-catheter in respect to providing additional guidewire support that is expected to allow easier crossing of femoropopliteal and infra-popliteal Chronic Total Occlusion (CTO) lesion. The procedure will be conducted on a patient diagnosed with a CTO in a peripheral vessel that requires revascularization.

Detailed Description
-----------------
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.

Conditions
-----------------
Chronic Total Occlusion

Intervention / Treatment
-----------------
* Device: NovaCross™ microcatheter


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective, non-randomized<br>use the NovaCross™micro-catheter in respect to providing additional guidewire support that is expected to allow easier crossing of femoropopliteal and infra-popliteal Chronic Total Occlusion (CTO) lesion | Device: NovaCross™ microcatheter<br>* successful delivery, crossing, and retrieval of the investigational device as identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events | absence of in-hospital or 30-days Major Adverse Events (MAEs) | 30 days | 
| Device success is defined as successful delivery, crossing, and retrieval of the investigational device as identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography | Successful femoropopliteal/infra popliteal CTO crossing using the NovaCross™ micro-catheter | in procedure |