Clinical trial NCT04862559: A Single Center Study to Evaluate the Safety of the NovaCross Microcatheter in Crossing Chronic Total Occlusions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Total Occlusion
Lead sponsor: Nitiloop Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-28
Enrollment: 15
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular Adverse Events (Primary Safety)
timeFrame: 30 days
measure: Technical Success (Primary Efficacy)
timeFrame: 1 day
Secondary outcomes:
measure: Procedural Success
timeFrame: 1 day
measure: Assistance in Guidewire Penetration
timeFrame: 1 day
measure: Crossability
timeFrame: 1 day
measure: Procedual Visualization
timeFrame: 1 day
measure: Operator Ease of Use
timeFrame: 1 day
measure: Device Related Perforation Rate
timeFrame: 1 day
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie
Study officials:
affiliation: Company Employee
name: Chanan Schneider, Mr.
role: STUDY_DIRECTOR
References: