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



Status:Not yet recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:25 - 80
Updated:11/8/2018
Start Date:November 2018
End Date:December 2019
Contact:Maya Shick
Email:maya@nitiloop.com
Phone:+972523355442

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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

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


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)
We found this trial at
3
sites
York, Pennsylvania 17315
Principal Investigator: William Nicholson, MD
Phone: 717-851-5153
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York, PA
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Little Rock, Arkansas 72205
Principal Investigator: Barry Uretsky, MD
Phone: 501-257-5893
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Little Rock, AR
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161 Fort Washington Avenue
New York, New York 10032
Principal Investigator: Dimitrios Kermpaliotis, MD
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New York, NY
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