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

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

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 Overview

• Status: Completed
• Conditions: Chronic Total Occlusion
• Intervention / Treatment: Device: NovaCross

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Kraków, Poland
    • Szpital Uniwersytecki w Krakowie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NovaCross; Subjects in this arm are treated with the investigational device, NovaCross micro-cetheter, to facilitate the opening of a chronic total occlusion (CTO)	Device: NovaCross; A device that is intended to asisst interventional cardiologists during catheterization to cross and open coronary chronic total occlusions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Adverse Events (Primary Safety)	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)).	30 days
Technical Success (Primary Efficacy)	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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success	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	1 day
Assistance in Guidewire Penetration	The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO	1 day
Crossability	The effectiveness of the extendable portion in intra-CTO microcatheter crossability	1 day
Procedual Visualization	The ability to have full visualization of the NovaCross during the CTO procedure	1 day
Operator Ease of Use	Assess the usability of the NovaCross™ by the operator	1 day
Device Related Perforation Rate	Device-related perforation at the site of target coronary lesion and/or its proximal reference segment	1 day

Collaborators and Investigators

• Sponsor: Nitiloop Ltd.
• Investigators: Study Director: Chanan Schneider, Mr., Company Employee

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): September 17, 2017
• Study Completion (Actual): September 17, 2017

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: NT-CLP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No