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This is an open label, single-center, prospective, pivotal study in which the investigational device, NovaCross™ micro-catheter, will be tested in up to 15 patients scheduled to undergo CTO-PCI using an anterograde approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NovaCross | Experimental | Subjects in this arm are treated with the investigational device, NovaCross micro-cetheter, to facilitate the opening of a chronic total occlusion (CTO) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovaCross | Device | A device that is intended to asisst interventional cardiologists during catheterization to cross and open coronary chronic total occlusions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Adverse Events (Primary Safety) | Accumulative incidence of Major Adverse Cardiovascular Events (MACE), defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)). | 30 days |
| Technical Success (Primary Efficacy) | 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 in the true vessel lumen | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success | 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 day |
| Assistance in Guidewire Penetration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chanan Schneider, Mr. | Company Employee | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szpital Uniwersytecki w Krakowie | Krakow | Poland |
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The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO |
| 1 day |
| Crossability | The effectiveness of the extendable portion in intra-CTO microcatheter crossability | 1 day |
| Procedual Visualization | The ability to have full visualization of the NovaCross during the CTO procedure | 1 day |
| Operator Ease of Use | Assess the usability of the NovaCross™ by the operator | 1 day |
| Device Related Perforation Rate | Device-related perforation at the site of target coronary lesion and/or its proximal reference segment | 1 day |