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

NitiLoop

Status: Completed

Conditions: Chronic Total Occlusion

Treatments: Device: NovaCross

Study type: Interventional

Funder types: Industry

Identifiers

NCT04862559

NT-CLP-02

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

NovaCross

Experimental group

Description:

Subjects in this arm are treated with the investigational device, NovaCross micro-cetheter, to facilitate the opening of a chronic total occlusion (CTO)

Treatment:

Device: NovaCross