Status:
COMPLETED
A Single Center Study to Evaluate the Safety of the NovaCross Microcatheter in Crossing Chronic Total Occlusions
Lead Sponsor:
Nitiloop Ltd.
Conditions:
Chronic Total Occlusion
Eligibility:
All Genders
25-80 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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 0.
- 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
- 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
Key Trial Info
Start Date :
February 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04862559
Start Date
February 1 2017
End Date
September 17 2017
Last Update
April 28 2021
Active Locations (1)
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1
Szpital Uniwersytecki w Krakowie
Krakow, Poland