CompletedNCT04862559Updated Apr 28, 2021

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

An interventional study of NovaCross in Chronic Total Occlusion, sponsored by Nitiloop Ltd.. Completed at 1 site in Poland. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by Nitiloop Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 4 years 2 months after the study started (first participant enrolled Feb 2017, registered Apr 2021).

Phase: Not applicable
Study type: Interventional
Enrollment: 15
Allocation: Not applicable
Ages: 25 Years to 80 Years
Sex: All

Study 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 an anterograde approach.

Conditions studied

Chronic Total Occlusion

In context

Lead sponsor

Nitiloop Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 25 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 15 participants (actual)

Study arms

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

Interventions

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

What researchers measure

Primary outcomes

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)).
Time frame: 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
Time frame: 1 day

Secondary outcomes

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
Time frame: 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
Time frame: 1 day
Crossability
The effectiveness of the extendable portion in intra-CTO microcatheter crossability
Time frame: 1 day
Procedual Visualization
The ability to have full visualization of the NovaCross during the CTO procedure
Time frame: 1 day
Operator Ease of Use
Assess the usability of the NovaCross™ by the operator
Time frame: 1 day
Device Related Perforation Rate
Device-related perforation at the site of target coronary lesion and/or its proximal reference segment
Time frame: 1 day

Study locations

1 site

Szpital Uniwersytecki w Krakowie
Kraków, Poland

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04862559
Lead sponsor: Nitiloop Ltd.
Responsible party: Sponsor
First posted: Apr 28, 2021
Start date: Feb 1, 2017
Primary completion: Sep 17, 2017
Completion: Sep 17, 2017
Last update: Apr 28, 2021

Study contacts

Chanan Schneider, Mr.

study director · Company Employee

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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