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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
145
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.
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States
Edward Hospital
Naperville, Illinois, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
York Hospital
York, Pennsylvania, United States
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)).
Time frame: 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.
Time frame: Intra-procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: Procedure
Visualization (ability to have full visualization of the NovaCross during the CTO procedure)
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SPZOZ University Hospital in Krakow
Krakow, Poland
4\. The ability to have full visualization of the NovaCross during the CTO procedure.
Time frame: Procedure
Usability (Assess the usability of the NovaCross™ by the operator)
5\. Assess the usability of the NovaCross™ by the operator.
Time frame: 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.
Time frame: Procedure