Cohort B of the Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

NitiLoop

Status: Unknown

Conditions: Coronary Occlusion

Treatments: Device: NovaCross

Study type: Interventional

Funder types: Industry

Identifiers

NCT03719014

NT-CLP-01 Cohort B

Details and patient eligibility

About

A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions

Enrollment: 60 estimated patients

Sex: All

Ages: 25 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, with a reference diameter of at least 2 millimeters.
• Left ventricle ejection fraction > 25%

Exclusion criteria

• Patient unable to give informed consent.

• Elevated CK-MB or troponin at baseline

• Patient is known or suspected not to tolerate the contrast agent

• Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion

• Appearance of a fresh thrombus or intraluminal filling defects

• Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor)

• Cardiac intervention within 4 weeks of the procedure

• Severe renal insufficiency with eGFR<30 ml/min/1.72 m2

• Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV

• Life expectancy < 2 years due to other illnesses

• Acute or unstable medical disorder/disease that may cause a risk to patient, including:

  i. Recent myocardial infarction (MI) (within the past two weeks) ii. Significant anemia (e.g. hemoglobin < 8.0 mg / dl) iii. Recent major cerebrovascular event (history of stroke or TIA within 1 month) iv. Severe uncontrolled systemic hypertension (e.g., >180/100 mmHg) v. Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

NovaCross

Experimental group

Description:

the NovaCross is a guidewire positioning and support micro-catheter 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 extandable segment, both at its distal tip.

Treatment:

Device: NovaCross