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

NCT03719014 | Unknown FDA Device

• 1 other identifier: NT-CLP-01 Cohort B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Conditions

Coronary Occlusion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Outcome Measure - Rate of procedure success

  Procedure

• Outcome Measure - Technical adaptation of the Micro-catheter to the guidewire

  Procedure

• Outcome Measure - Effective micro-catheter crossability

  Procedure

• Outcome Measure - Ease of Use

  Procedure

• Safety Measure - Myocardial Infraction (MI) rate

  up to 30 days

Study Arms (1)

NovaCross

EXPERIMENTAL

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

Interventions

NovaCross DEVICE

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.

NovaCross

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Nitiloop Ltd.: lead

Study Sites (3)

Little Rock Medical Center

Little Rock, Arkansas, 72205, United States

Location

Nyph/Cumc

New York, New York, 10032, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

MeSH Terms

Conditions

Coronary Occlusion

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Simon Walsh, MD

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Shick

CONTACT

+972523355442; maya@nitiloop.com

Itamar Haran

CONTACT

+972549985610; itamar@nitiloop.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open label, multi-center, prospective, supplemental study in which the device, NovaCross™ CTO micro-catheter, will be tested in up to 60 patients scheduled to undergo CTO-PCI using an anterograde approach

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 25, 2018
• Study Start: November 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 6, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)