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ClinicalTrials.gov ID

NCT03719014

Lead Sponsor

Nitiloop Ltd.INDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

60Estimated

Last Update Posted

Nov 6, 2018Actual

Start Date

Nov 2018Estimated

Primary Completion Date

Apr 2019Estimated

Completion Date

Dec 2019Estimated

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

Brief Summary

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

• Coronary Occlusion

• NovaCross

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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, 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)

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Nitiloop Ltd.INDUSTRY

keb2114@cumc.columbia.edu

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