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Clinical 

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MULTI-CENTER PIVOTAL STUDY 

Nitiloop successfully completed a non-randomized, open label, single arm pivotal study that assessed the safety and efficacy of its NovaCross™ device in subjects undergoing Percutaneous Cardiac Intervention for Chronic Total Occlusion (NCT02379923).
 

Following the study, the device was cleared in the USA under FDA K193322.
 

The study included 10 sites in the USA and Europe (Netherlands, Poland, Israel, UK and Ireland). 186 subjects were included in the study, which included the screening procedures, the procedure itself, and follow-up for 30 days post procedure or hospital discharge.
 

The results of the combined cohorts show a protocol defined MI rate of 12.3% for the ITT population and 11.7% for the PP population (primary safety endpoint).  Secondary endpoints included MI rate according to the SCAI definition - 2.2% and 3rd universal definition- 3.2%. Possible device related perforation was 2.2% (4/186). 

 

The primary efficacy endpoint was the rate of 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. The results showed a technical success rate of 75.3% (140/186), meeting the pre-defined 54% goal. Proximal cap penetration was successful in 89.2% (166/186).

Nitiloop completed a pivotal clinical study that assessed the safety and efficacy of the NovaCross device for revascularization of coronary CTO.   The study included 186 patients in 10 centers in the U.S., Europe and Israel.
 

STUDY HIGHLIGHTS    

 

       High efficacy 76%

       Antegrade technical success 88%
       Technical success rate: 75.3%

       

       Safety Results (MACE)

       - Death: 0%

       - Possible device related perforation: 2.2%

       - Bypass surgery - 0%

       - MI ≤ 12.3 % (CKMB>3ULN)


Based on the study, the NovaCross received FDA clearance

for treating CTO prior to PTCA or Stent Intervention 

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CLINICAL MILESTONES

Nitiloop completed a pivotal clinical study that assessed the safety and efficacy of the NovaCross™ device for revascularization of coronary CTO.   The study included 186 patients in 10 centers in the U.S., Europe and Israel.
 

STUDY HIGHLIGHTS    

 

  • High efficacy: 76%

  • Antegrade technical success: 88%

  • Technical success rate: 75.3%

       

  •  Safety Results (MACE)

       - Death: 0%

       - Device related perforation: 2.2%

       - Bypass surgery: 0%

       - MI ≤ 12.3 % (CKMB>3ULN)


Based on the study, the NovaCross™ received FDA clearance

for treating CTO prior to PTCA or Stent Intervention. 

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 ARTICLES

1. Walsh S, Dudek D, Bryniarski L, et al. Efficacy and Safety of Novel NovaCross™ Microcatheter for Chronic Total Occlusions: First-in-Human Study. J Invasive Cardiol. 2016;28(3):88‐91.

2. Walsh, Simon J.  ; Dudek, Darius  ; Bryniarski, Leszek  ; Nicholson, William   ; Karmpaliotis, Dimtri   ; Uretsky, Barry   ; McEntegart, Margaret  ; Assali, Abid  ; Knaapen, Paul  ; Kornowski, Ran   ; Spratt, James C.    ; Goodwin, Mark   ; Hanratty, Colm G.   Safety and efficacy of the NovaCross microcatheter in facilitating crossing of chronic total occlusion coronary lesions, Coronary Artery Disease: August 27, 2020 - Volume Publish Ahead of Print - Issue - doi: 10.1097/MCA.0000000000000947 

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