Cohort B of the Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

Study Overview
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Brief Summary
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A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions

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

Conditions
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Coronary Occlusion

Intervention / Treatment
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* Device: NovaCross


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult aged 25-80 Patient understands and has signed the study informed consent form Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration) showing distal TIMI flow 0, with a reference diameter of at least 2 millimeters. Left ventricle ejection fraction > 25% Exclusion Criteria: Patient unable to give informed consent. Elevated CK-MB or troponin at baseline Patient is known or suspected not to tolerate the contrast agent Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion Appearance of a fresh thrombus or intraluminal filling defects Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor) Cardiac intervention within 4 weeks of the procedure Severe renal insufficiency with eGFR<30 ml/min/1.72 m2 Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV Life expectancy < 2 years due to other illnesses Acute or unstable medical disorder/disease that may cause a risk to patient, including: i. Recent myocardial infarction (MI) (within the past two weeks) ii. Significant anemia (e.g. hemoglobin < 8.0 mg / dl) iii. Recent major cerebrovascular event (history of stroke or TIA within 1 month) iv. Severe uncontrolled systemic hypertension (e.g., >180/100 mmHg) v. Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 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
Interventional Model Description: This is an open label, multi-center, prospective, supplemental study in which the device, NovaCross™ CTO micro-catheter, will be tested in up to 60 patients scheduled to undergo CTO-PCI using an anterograde approach
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NovaCross<br>the NovaCross is a guidewire positioning and support micro-catheter for improving chronic total occlusion (CTO) crossability. The NovaCross gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extandable segment, both at its distal tip. | Device: NovaCross<br>* The NovaCross micro-catheter will be used during a standard of care Percutanous Coronary Intervention (PCI) on subjects diagnosed with at least one coronary chronic total occlusion (CTO), in order to assist the operator in guidewire stability and centralization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Measure - Rate of in-hospital MACE events | Defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)). | up to 30 days | 
| Primary Outcome Measure - Intra-procedural technical succees | 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 (CTO) in the true vessel lumen | Intra-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome Measure - Rate of procedure 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 | Procedure | 
| Outcome Measure - Technical adaptation of the Micro-catheter to the guidewire | The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO | Procedure | 
| Outcome Measure - Effective micro-catheter crossability | The effectiveness of the extendable portion in intra-CTO microcatheter crossability | Procedure | 
| Outcome Measure - Ease of Use | Operator's ability to visualize the NoveCross micro-catheter throughout the procedure, as well as to assess the ease of use of the NovaCross | Procedure | 
| Safety Measure - Myocardial Infraction (MI) rate | Rate of MI events, as defined according to the SCAI and 3rd universal definitions. | up to 30 days |