A Prospective, Multi-Center, Pivotal Study to Evaluate th... | NCT02477579

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
NovaCross	Experimental	NovaCross microcatheter will be used.	Device: NovaCross

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NovaCross	Device	The NovaCross™ is a guidewire positioning and support microcatheter for improving chronic total occlusion (CTO) crossability. The NovaCross™ gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extendable segment, both at its distal tip.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE	30 day 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
Intra-procedural technical success	Intra-procedural technical success, defined as the ability of the NovaCross™ micro-catheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion (CTO) in the true vessel lumen.	Intra-procedure

Secondary Outcomes

Measure	Description	Time Frame
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.	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.

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Central Arkansas Veterans Healthcare System		Little Rock	Arkansas	72205	United States
Edward Hospital

Type	Date	Date Unknown
Release	Dec 4, 2019
Reset	Dec 18, 2019