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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Little Rock Medical Center
Little Rock, Arkansas, United States
Nyph/Cumc
New York, New York, United States
York Hospital
York, Pennsylvania, United States
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)).
Time frame: 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
Time frame: Intra-procedure
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
Time frame: 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
Time frame: Procedure
Outcome Measure - Effective micro-catheter crossability
The effectiveness of the extendable portion in intra-CTO microcatheter crossability
Time frame: 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
Time frame: Procedure
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Safety Measure - Myocardial Infraction (MI) rate
Rate of MI events, as defined according to the SCAI and 3rd universal definitions.
Time frame: up to 30 days