NCT04862559CompletedNot Applicable
A Prospective, Single Center, Non-randomized, Single Arm, Open Label, Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
Nitiloop Ltd.1 site in 1 country15 target enrollmentStarted: February 1, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Cardiovascular Adverse Events (Primary Safety)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult aged 25-80
- •Patient understands and has signed the study informed consent form.
- •Patient is a suitable candidate for non-emergent, coronary angioplasty
- •Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration either by documentation or PI assessment Investigator) showing distal TIMI flow
- •Coronary angiography of CTO lesion reveals satisfactory distal vessel visualization
- •CTO lesion is located in a coronary vessel with a reference diameter of at least 2 millimeters.
- •CTO lesion is suitable for antegrade approach.
- •Left ventricle ejection fraction > 25%
- •Body Mass Index (BMI) < 40
Exclusion Criteria
- •Patient unable to give informed consent.
- •Patient is participating in another study with any investigational drug or device.
- •Patient is known or suspected not to tolerate the contrast agent.
- •Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO.
- •Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
- •Appearance of a fresh thrombus or intraluminal filling defects.
- •Recent major cerebrovascular event (stroke or TIA within 30 days)
- •Significant anemia (hemoglobin < 8.0 mg / dl)
- •Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
- •Recent myocardial infarction (MI) (within the past two weeks)
- •Unwillingness or inability to comply with any protocol requirements
- •Pregnancy or nursing
Outcomes
Primary Outcomes
Cardiovascular Adverse Events (Primary Safety)
Time Frame: 30 days
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)).
Technical Success (Primary Efficacy)
Time Frame: 1 day
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
Secondary Outcomes
- Crossability(1 day)
- Procedual Visualization(1 day)
- Operator Ease of Use(1 day)
- Procedural Success(1 day)
- Assistance in Guidewire Penetration(1 day)
- Device Related Perforation Rate(1 day)
Investigators
Study Sites (1)
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