Coronary Occlusion
Conditions
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
Interventions
DEVICENovaCross
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.
Sponsors
Nitiloop Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult aged 25-80 * Patient understands and has signed the study informed consent form * 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. * Left ventricle ejection fraction \> 25%
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Outcome Measure - Effective micro-catheter crossability | Procedure | The effectiveness of the extendable portion in intra-CTO microcatheter crossability |
| 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 |
| Safety Measure - Myocardial Infraction (MI) rate | up to 30 days | Rate of MI events, as defined according to the SCAI and 3rd universal definitions. |
| 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 |
| 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 |
Countries
United States
Contacts
Primary ContactMaya Shick
Backup ContactItamar Haran
Outcome results
None listed