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.
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
40
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.
Rabin Medical Center
Petah Tikva, Israel
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Poland
Belfast City Hospital
Belfast, United Kingdom
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)).
Time frame: 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
Time frame: during the procedure
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
Time frame: 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
Time frame: during the procedure
Crossability
The effectiveness of the extendable portion in intra-CTO microcatheter crossability
Time frame: 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
Time frame: during the procedure
Myocardial Infraction (MI) Rate
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
In hospital MI rate
Time frame: up to 30 days
Device Related Adverse Events
Device-related perforation at the site of target coronary lesion and/or its proximal reference segment
Time frame: up to 30 days