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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
A device that is intended to asisst interventional cardiologists during catheterization to cross and open coronary chronic total occlusions
Szpital Uniwersytecki w Krakowie
Krakow, Poland
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)).
Time frame: 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
Time frame: 1 day
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
Time frame: 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
Time frame: 1 day
Crossability
The effectiveness of the extendable portion in intra-CTO microcatheter crossability
Time frame: 1 day
Procedual Visualization
The ability to have full visualization of the NovaCross during the CTO procedure
Time frame: 1 day
Operator Ease of Use
Assess the usability of the NovaCross™ by the operator
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Time frame: 1 day
Device Related Perforation Rate
Device-related perforation at the site of target coronary lesion and/or its proximal reference segment
Time frame: 1 day