Cohort B of the Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NovaCross 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. |
Device: NovaCross
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.
|
Outcome Measures
Primary Outcome Measures
- Primary Safety Measure - Rate of in-hospital MACE events [up to 30 days]
Defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).
- Primary Outcome Measure - Intra-procedural technical succees [Intra-procedure]
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
Secondary Outcome Measures
- Outcome Measure - Rate of procedure success [Procedure]
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
- Outcome Measure - Technical adaptation of the Micro-catheter to the guidewire [Procedure]
The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO
- Outcome Measure - Effective micro-catheter crossability [Procedure]
The effectiveness of the extendable portion in intra-CTO microcatheter crossability
- Outcome Measure - Ease of Use [Procedure]
Operator's ability to visualize the NoveCross micro-catheter throughout the procedure, as well as to assess the ease of use of the NovaCross
- Safety Measure - Myocardial Infraction (MI) rate [up to 30 days]
Rate of MI events, as defined according to the SCAI and 3rd universal definitions.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult aged 25-80
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Patient understands and has signed the study informed consent form
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Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration) showing distal TIMI flow 0, with a reference diameter of at least 2 millimeters.
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Left ventricle ejection fraction > 25%
Exclusion Criteria:
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Patient unable to give informed consent.
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Elevated CK-MB or troponin at baseline
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Patient is known or suspected not to tolerate the contrast agent
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Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion
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Appearance of a fresh thrombus or intraluminal filling defects
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Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor)
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Cardiac intervention within 4 weeks of the procedure
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Severe renal insufficiency with eGFR<30 ml/min/1.72 m2
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Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV
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Life expectancy < 2 years due to other illnesses
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Acute or unstable medical disorder/disease that may cause a risk to patient, including:
- 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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Little Rock Medical Center | Little Rock | Arkansas | United States | 72205 |
| 2 | Nyph/Cumc | New York | New York | United States | 10032 |
| 3 | York Hospital | York | Pennsylvania | United States | 17403 |
Sponsors and Collaborators
- Nitiloop Ltd.
Investigators
- Principal Investigator: Simon Walsh, MD, Belfast Health and Social Care Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NT-CLP-01 Cohort B