A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions

Study Overview
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Brief Summary
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This study evaluates the safety and effectiveness of the a novel device called NovaCross to help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.

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, 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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Chronic Total Occlusion of Coronary Artery

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. Suitable candidate for non-emergent, coronary angioplasty Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches Body Mass Index (BMI) < 40 Left ventricle ejection fraction > 25% Exclusion Criteria: Patient unable to give informed consent. Current participation in another study with any investigational drug or device. Patient is known or suspected not to tolerate the contrast agent. Aorta-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent 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 (history of stroke or TIA within 1 month) Cardiac intervention within 4 weeks of the procedure Renal insufficiency (serum creatinine of > 2.3mg/dl or 203μmol/L) Active gastrointestinal bleeding Active infection or fever that may be due to infection Life expectancy < 2 years due to other illnesses Significant anemia (hemoglobin < 8.0 mg / dl) Severe uncontrolled systemic hypertension (> 240 mmHg within 1 month of procedure) Severe electrolyte imbalance Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV. 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) Uncontrolled diabetes >2 serum glucose concentrations of >350 mg/dl within 7 days. Unwillingness or inability to comply with any protocol requirements Pregnant or nursing Extensive prior dissection from a coronary guidewire use Drug abuse or alcoholism. Patients under custodial care. Bleeding diathesis or coagulation disorder; Kawasaki's disease or other vasculitis

Ages Eligible for Study
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Minimum Age: 18 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: NovaCross<br>NovaCross microcatheter will be used. | Device: NovaCross<br>* The NovaCross™ is a guidewire positioning and support microcatheter 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, both at its distal tip.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | 30 day 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 | 
| Intra-procedural technical success | Intra-procedural technical success, defined as the ability of the NovaCross™ micro-catheter 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 |
| --- | --- | --- |
| 1. 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. 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 | 
| Proximal cap (ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.) | 2. The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO. | Procedure | 
| Effectiveness of extendable portion (effectiveness of the extendable portion in intra-CTO microcatheter crossability) | 3. The effectiveness of the extendable portion in intra-CTO microcatheter crossability. | Procedure | 
| Visualization (ability to have full visualization of the NovaCross during the CTO procedure) | 4. The ability to have full visualization of the NovaCross during the CTO procedure. | Procedure | 
| Usability (Assess the usability of the NovaCross™ by the operator) | 5. Assess the usability of the NovaCross™ by the operator. | Procedure | 
| Device-related perforation (at the site of target coronary lesion and/or its proximal reference segment) | 6. Device-related perforation at the site of target coronary lesion and/or its proximal reference segment. | Procedure |