A Single Center Study to Evaluate the Safety of the NovaCross Microcatheter in Crossing Chronic Total Occlusions

Launched by NITILOOP LTD. · Apr 23, 2021

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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 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 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