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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Occlusion
• Intervention / Treatment: Device: NovaCross

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Shick; Phone Number: +972523355442; Email: maya@nitiloop.com
• Study Contact Backup: Name: Itamar Haran; Phone Number: +972549985610; Email: itamar@nitiloop.com

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Medical Center
      • Contact: Kristin Miller; Phone Number: 501-257-5893; Email: kristin.miller@va.gov
  • New York
    • New York, New York, United States, 10032
      • Nyph/Cumc
      • Contact: Kate Dalton; Email: Keb2114@cumc.columbia.edu
      • Principal Investigator: Dimitrios Kermpaliotis, MD
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • York Hospital
      • Principal Investigator: William Nicholson, MD
      • Contact: Sarah Lake; Phone Number: 717-851-5153; Email: slake@wellspan.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NovaCross; 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.	Device: NovaCross; The NovaCross micro-catheter will be used during a standard of care Percutanous Coronary Intervention (PCI) on subjects diagnosed with at least one coronary chronic total occlusion (CTO), in order to assist the operator in guidewire stability and centralization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Measure - Rate of in-hospital MACE events	Defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).	up to 30 days
Primary Outcome Measure - Intra-procedural technical succees	Intra-procedural technical success defined as the ability of the NovaCross™ microcatheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion (CTO) in the true vessel lumen	Intra-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcome Measure - Rate of procedure success	The ability to cross the lesion with a guidewire in the true lumen, effectively dilate the CTO lesion, and place a coronary stent with residual lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow	Procedure
Outcome Measure - Technical adaptation of the Micro-catheter to the guidewire	The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO	Procedure
Outcome Measure - Effective micro-catheter crossability	The effectiveness of the extendable portion in intra-CTO microcatheter crossability	Procedure
Outcome Measure - Ease of Use	Operator's ability to visualize the NoveCross micro-catheter throughout the procedure, as well as to assess the ease of use of the NovaCross	Procedure
Safety Measure - Myocardial Infraction (MI) rate	Rate of MI events, as defined according to the SCAI and 3rd universal definitions.	up to 30 days

Collaborators and Investigators

• Sponsor: Nitiloop Ltd.
• Investigators: Principal Investigator: Simon Walsh, MD, Belfast Health and Social Care Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Occlusion
• Other Study ID Numbers: NT-CLP-01 Cohort B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes