Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

NitiLoop

Status: Completed

Conditions: Coronary Occlusion

Treatments: Device: NovaCross™ Chronic Total Occlusion micro-catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT03717675

NT-CLP-03

Details and patient eligibility

About

This study will include up to 60 eligible male and female subjects. 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. This study is an extension study of Nitiloop's Pivotal study.

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: 40 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult aged 25-80
2. Patient understands and has signed the study informed consent form
3. 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.
4. Left ventricle ejection fraction > 25%

Exclusion criteria

1. Patient unable to give informed consent. 2. Elevated CK-MB or troponin at baseline 3. Patient is known or suspected not to tolerate the contrast agent 4. Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion 5. Appearance of a fresh thrombus or intraluminal filling defects 6. Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor) 7. Cardiac intervention within 4 weeks of the procedure 8. Severe renal insufficiency with eGFR<30 ml/min/1.72 m2 9. Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV 10. Life expectancy < 2 years due to other illnesses 11. 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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40 participants in 1 patient group

Interventional

Experimental group

Description:

Interventional arm, where the NovaCross™ CTO micro-catheter will be placed in study subjects during the Total Occlusion opening procedure.

Treatment:

Device: NovaCross™ Chronic Total Occlusion micro-catheter