Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

Study Overview
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Brief Summary
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This study will include up to 60 eligible male and female subjects. The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt. This study is an extension study of Nitiloop's Pivotal study.

Detailed Description
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The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.

Official Title
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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

Conditions
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Coronary Occlusion

Intervention / Treatment
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* Device: NovaCross™ Chronic Total Occlusion micro-catheter


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: 1. Patient unable to give informed consent. 2. Elevated CK-MB or troponin at baseline 3. Patient is known or suspected not to tolerate the contrast agent 4. Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion 5. Appearance of a fresh thrombus or intraluminal filling defects 6. Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor) 7. Cardiac intervention within 4 weeks of the procedure 8. Severe renal insufficiency with eGFR<30 ml/min/1.72 m2 9. Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV 10. Life expectancy < 2 years due to other illnesses 11. 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Interventional arm, where the NovaCross™ CTO micro-catheter will be placed in study subjects during the Total Occlusion opening procedure. | Device: NovaCross™ Chronic Total Occlusion micro-catheter<br>* The NovaCross™ micro catheter 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 extendable segment. Investigators will use the NovaCross Micro catheter during a standard of care catheterization of patients diagnosed with coronary total occlusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint - 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)). | until discharge or 30 days, the sooner of the two | 
| Primary Efficacy Endpoint - 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 | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Lesion Crossing | 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 | during the procedure | 
| Guidewire Facilitation and rate of successful penetration to the CTO | The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO | during the procedure | 
| Crossability | The effectiveness of the extendable portion in intra-CTO microcatheter crossability | during the procedure | 
| Investigator visualization and ease of use | The ability to have full visualization of the NovaCross during the CTO procedure and assessing the usability of the device | during the procedure | 
| Myocardial Infraction (MI) Rate | In hospital MI rate | up to 30 days | 
| Device Related Adverse Events | Device-related perforation at the site of target coronary lesion and/or its proximal reference segment | up to 30 days |