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Completed

NCT Number: NCT04862559

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

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.

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Key information

Conditions

Chronic Total Occlusion

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Szpital Uniwersytecki w Krakowie

Krakow, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NovaCross

Device

A device that is intended to asisst interventional cardiologists during catheterization to cross and open coronary chronic total occlusions

Primary outcomes

  1. 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)).

  2. 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

  1. Procedural Success

    Time frame: 1 day

    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

  2. Assistance in Guidewire Penetration

    Time frame: 1 day

    The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO

  3. Crossability

    Time frame: 1 day

    The effectiveness of the extendable portion in intra-CTO microcatheter crossability

  4. Procedual Visualization

    Time frame: 1 day

    The ability to have full visualization of the NovaCross during the CTO procedure

  5. Operator Ease of Use

    Time frame: 1 day

    Assess the usability of the NovaCross™ by the operator

  6. Device Related Perforation Rate

    Time frame: 1 day

    Device-related perforation at the site of target coronary lesion and/or its proximal reference segment

Sponsors and collaborators

Lead sponsor

Nitiloop Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2021
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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