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Efficacy and Safety of Novel NovaCross Microcatheter for Chronic Total Occlusions: First-in-Human Study
Simon Walsh1, Dariusz Dudek, Leszek Bryniarski
1Belfast Health & Social Care Trust, Cardiology, Belfast, Ireland. Simon.Walsh@belfasttrust.hscni.net.
Objectives:
The aim of this first-in-human (FIH) study was to evaluate the efficacy and safety of the novel NovaCross microcatheter system in eligible consecutive patients with chronic total occlusion (CTO).
Background:
CTOs remain the most challenging lesion subset in percutaneous coronary intervention (PCI). Failure to cross to the distal true lumen with the guidewire is one of the major causes of procedural failure in CTO-PCI. The NovaCross microcatheter (Nitiloop, Ltd) is designed to improve antegrade recanalization success.
Methods:
This study was a prospective, non-randomized, FIH investigational study. Patients with total occlusion of a coronary artery determined to be more than 3 months old and accepted for coronary CTO-PCI with an intended antegrade strategy were enrolled.
Results:
Twenty-four patients were enrolled in this study. Despite the high complexity of the lesions (including 80% J-CTO score ≥3 and 50% of the cases having had a previous failed CTO-PCI attempt), technical success was 81.8%. No patients reported any major adverse cardiac event up to and including 30 days post procedure.
Conclusion:
In this FIH study, the NovaCross microcatheter exhibited the potential to stabilize guidewires and enhance crossing of coronary CTO lesions.
Insights
The NovaCross microcatheter shows promise for improving guidewire crossing in challenging coronary chronic total occlusions (CTOs). This first-in-human study demonstrated its potential for successful percutaneous coronary intervention (PCI) in CTO lesions.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Coronary chronic total occlusions (CTOs) represent a significant challenge in percutaneous coronary intervention (PCI).
- Guidewire crossing failure is a primary reason for procedural failure in CTO interventions.
- The NovaCross microcatheter is a novel device engineered to facilitate antegrade recanalization in CTOs.
Purpose of the Study:
- To assess the efficacy and safety of the NovaCross microcatheter system.
- To evaluate the device in patients undergoing coronary CTO intervention.
- This was a first-in-human (FIH) investigation.
Main Methods:
- Prospective, non-randomized, first-in-human investigational study design.
- Enrollment of consecutive patients with coronary artery CTOs (≥3 months duration).
- Patients were selected for coronary CTO-PCI with an antegrade recanalization strategy.
Main Results:
- Twenty-four patients were enrolled in the study.
- High lesion complexity was observed (80% J-CTO score ≥3, 50% prior failed attempts).
- Technical success rate was 81.8% with no major adverse cardiac events within 30 days.
Conclusions:
- The NovaCross microcatheter demonstrated potential in stabilizing guidewires.
- The device showed promise in enhancing the crossing of coronary CTO lesions.
- This FIH study supports further investigation of the NovaCross system.
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