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A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NovaCross | Experimental | the NovaCross 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 extandable segment, both at its distal tip. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovaCross | Device | The NovaCross micro-catheter will be used during a standard of care Percutanous Coronary Intervention (PCI) on subjects diagnosed with at least one coronary chronic total occlusion (CTO), in order to assist the operator in guidewire stability and centralization. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Measure - 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)). | up to 30 days |
| Primary Outcome Measure - Intra-procedural technical succees | 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 | Intra-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome Measure - Rate of procedure 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 | Procedure |
| Outcome Measure - Technical adaptation of the Micro-catheter to the guidewire |
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Inclusion Criteria:
Exclusion Criteria:
Patient unable to give informed consent.
Elevated CK-MB or troponin at baseline
Patient is known or suspected not to tolerate the contrast agent
Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion
Appearance of a fresh thrombus or intraluminal filling defects
Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor)
Cardiac intervention within 4 weeks of the procedure
Severe renal insufficiency with eGFR<30 ml/min/1.72 m2
Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV
Life expectancy < 2 years due to other illnesses
Acute or unstable medical disorder/disease that may cause a risk to patient, including:
i. Recent myocardial infarction (MI) (within the past two weeks) ii. Significant anemia (e.g. hemoglobin < 8.0 mg / dl) iii. Recent major cerebrovascular event (history of stroke or TIA within 1 month) iv. Severe uncontrolled systemic hypertension (e.g., >180/100 mmHg) v. Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Shick | Contact | +972523355442 | maya@nitiloop.com | |
| Itamar Haran | Contact | +972549985610 | itamar@nitiloop.com |
| Name | Affiliation | Role |
|---|---|---|
| Simon Walsh, MD | Belfast Health and Social Care Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock Medical Center | Little Rock | Arkansas | 72205 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 2, 2019 | |
| Reset | Dec 16, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 2, 2019 | Dec 16, 2019 |
| ID | Term |
|---|---|
| D054059 | Coronary Occlusion |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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This is an open label, multi-center, prospective, supplemental study in which the device, NovaCross™ CTO micro-catheter, will be tested in up to 60 patients scheduled to undergo CTO-PCI using an anterograde approach
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|
The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO |
| Procedure |
| Outcome Measure - Effective micro-catheter crossability | The effectiveness of the extendable portion in intra-CTO microcatheter crossability | Procedure |
| Outcome Measure - Ease of Use | Operator's ability to visualize the NoveCross micro-catheter throughout the procedure, as well as to assess the ease of use of the NovaCross | Procedure |
| Safety Measure - Myocardial Infraction (MI) rate | Rate of MI events, as defined according to the SCAI and 3rd universal definitions. | up to 30 days |
| Nyph/Cumc | New York | New York | 10032 | United States |
|
| York Hospital | York | Pennsylvania | 17403 | United States |
|
| D014652 |
| Vascular Diseases |