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

Chronic Total Occlusion Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862559
• Other study ID #: NT-CLP-02
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: September 17, 2017

Study information

• Verified date: September 2016
• Source: Nitiloop Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 17, 2017
• Est. primary completion date: September 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Total Occlusion

Intervention

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

Locations

Country	Name	City	State
Poland	Szpital Uniwersytecki w Krakowie	Kraków

Sponsors (1)

Lead Sponsor	Collaborator
Nitiloop Ltd.

Country where clinical trial is conducted

Poland, 

Outcome

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