A Single Center Study to Evaluate the Safety of the NovaCross Microcatheter in Crossing Chronic Total Occlusions

Study Overview
=================
Brief Summary
-----------------
This is an open label, single-center, prospective, pivotal study in which the investigational device, NovaCross™ micro-catheter, will be tested in up to 15 patients scheduled to undergo CTO-PCI using an anterograde approach.

Official Title
-----------------
A Prospective, Single Center, Non-randomized, Single Arm, Open Label, Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult aged 25-80 Patient understands and has signed the study informed consent form. Patient is a suitable candidate for non-emergent, coronary angioplasty Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration either by documentation or PI assessment Investigator) showing distal TIMI flow 0. Coronary angiography of CTO lesion reveals satisfactory distal vessel visualization CTO lesion is located in a coronary vessel with a reference diameter of at least 2 millimeters. CTO lesion is suitable for antegrade approach. Left ventricle ejection fraction > 25% Body Mass Index (BMI) < 40 Exclusion Criteria: Patient unable to give informed consent. Patient is participating in another study with any investigational drug or device. Patient is known or suspected not to tolerate the contrast agent. Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO. Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor). Appearance of a fresh thrombus or intraluminal filling defects. Recent major cerebrovascular event (stroke or TIA within 30 days) Significant anemia (hemoglobin < 8.0 mg / dl) Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) Recent myocardial infarction (MI) (within the past two weeks) Unwillingness or inability to comply with any protocol requirements Pregnancy or nursing

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: NovaCross<br>Subjects in this arm are treated with the investigational device, NovaCross micro-cetheter, to facilitate the opening of a chronic total occlusion (CTO) | Device: NovaCross<br>* A device that is intended to asisst interventional cardiologists during catheterization to cross and open coronary chronic total occlusions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Adverse Events (Primary Safety) | Accumulative incidence of Major Adverse Cardiovascular Events (MACE), defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)). | 30 days | 
| Technical Success (Primary Efficacy) | Intra-procedural technical success, defined as the ability of the NovaCross™ microcatheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion in the true vessel lumen | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | The ability to cross the lesion with a guidewire in the true lumen, effectively dilate the CTO lesion, and place a coronary stent with residual lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow | 1 day | 
| Assistance in Guidewire Penetration | The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO | 1 day | 
| Crossability | The effectiveness of the extendable portion in intra-CTO microcatheter crossability | 1 day | 
| Procedual Visualization | The ability to have full visualization of the NovaCross during the CTO procedure | 1 day | 
| Operator Ease of Use | Assess the usability of the NovaCross™ by the operator | 1 day | 
| Device Related Perforation Rate | Device-related perforation at the site of target coronary lesion and/or its proximal reference segment | 1 day |