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

NitiLoop

Status

Completed

Conditions

Chronic Total Occlusion of Coronary Artery

Treatments

Device: NovaCross

Study type

Interventional

Funder types

Industry

Identifiers

NCT02477579

NT-CLP-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

145 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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