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

Status unconfirmed · Not applicable

Conditions studied: Coronary Occlusion

In brief

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

Key facts

Study ID

NCT03719014

Run by

Nitiloop Ltd.

People needed

60

Starts

2018-11-01

Expected to finish

2019-12-01

Last updated by the study team

2018-11-06

Who can join

Age: 25 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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)

Where it is running

• Little Rock Medical Center — Little Rock, Arkansas, United States
• Nyph/Cumc — New York, New York, United States
• York Hospital — York, Pennsylvania, United States

Full record on ClinicalTrials.gov

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