This is a prospective, non-randomized, first-in-man investigational study, to assess the safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™ micro-catheter during an interventional coronary angioplasty procedure and evaluating the CTO penetration rate. Each study subject/patient will have a total of one (1) procedure performed for this study.
To be filled later
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
evaluate the safety and performance of the NovaCross™ micro-catheter in respect to providing additional guidewire support that is expected to allow easier crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries.
Hadasa Ei Karem
Jerusalem, Israel, Israel
lack of device related major adverse event
. 30-day Lack of device-related Major Adverse Cardiac Event Rate (MACE) at the site of target coronary lesion and/or its proximal reference segment. Time Frame:
Time frame: 30 days
Maneuverability of the NovaCross ™ up to the occlusion and safe withdrawal
Maneuverability of the NovaCross ™ up to the occlusion and safe withdrawal.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% and restoring antegrade TIMI 3 flow.
Time frame: During Procedure
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