Clinical trial NCT02477579: A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
Official title: A Prospective, Multi-Center, Non-randomized, Single Arm, Open Label, Pivotal 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 of Coronary Artery
Lead sponsor: Nitiloop Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-23
Enrollment: 145
Sex: ALL
Minimum age (years): 18
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 study evaluates the safety and effectiveness of the a novel device called NovaCross to help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.

Detailed description: The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.

Eligibility criteria: Inclusion Criteria:

* Adult aged 25-80
* Patient understands and has signed the study informed consent form.
* Patient has an angiographic documented Chronic Total Occlusion (i.e. \>3 months occlusion duration) showing distal TIMI flow 0.
* Suitable candidate for non-emergent, coronary angioplasty
* Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches
* Body Mass Index (BMI) \< 40
* Left ventricle ejection fraction \> 25%

Exclusion Criteria:

* Patient unable to give informed consent.
* Current participation in another study with any investigational drug or device.
* Patient is known or suspected not to tolerate the contrast agent.
* Aorta-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent 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 (history of stroke or TIA within 1 month)
* Cardiac intervention within 4 weeks of the procedure
* Renal insufficiency (serum creatinine of \> 2.3mg/dl or 203μmol/L)
* Active gastrointestinal bleeding
* Active infection or fever that may be due to infection
* Life expectancy \< 2 years due to other illnesses
* Significant anemia (hemoglobin \< 8.0 mg / dl)
* Severe uncontrolled systemic hypertension (\> 240 mmHg within 1 month of procedure)
* Severe electrolyte imbalance
* Congestive heart failure \[New York Heart Association (NYHA) Class III\\IV\] CSA Class IV.
* 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)
* Uncontrolled diabetes \>2 serum glucose concentrations of \>350 mg/dl within 7 days.
* Unwillingness or inability to comply with any protocol requirements
* Pregnant or nursing
* Extensive prior dissection from a coronary guidewire use
* Drug abuse or alcoholism.
* Patients under custodial care.
* Bleeding diathesis or coagulation disorder;
* Kawasaki's disease or other vasculitis

Primary outcomes:
measure: MACE
timeFrame: 30 days
measure: Intra-procedural technical success
timeFrame: Intra-procedure
Secondary outcomes:
measure: 1. 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.
timeFrame: Procedure
measure: Proximal cap (ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.)
timeFrame: Procedure
measure: Effectiveness of extendable portion (effectiveness of the extendable portion in intra-CTO microcatheter crossability)
timeFrame: Procedure
measure: Visualization (ability to have full visualization of the NovaCross during the CTO procedure)
timeFrame: Procedure
measure: Usability (Assess the usability of the NovaCross™ by the operator)
timeFrame: Procedure
measure: Device-related perforation (at the site of target coronary lesion and/or its proximal reference segment)
timeFrame: Procedure
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
city: Naperville
country: United States
facility: Edward Hospital
state: Illinois
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian Hospital
state: New York
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Krakow
country: Poland
facility: SPZOZ University Hospital in Krakow
Study officials:
affiliation: Belfast Health and Social Care Trust
name: Simon Walsh, MD
role: PRINCIPAL_INVESTIGATOR
References: