Back to results

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

Primary Purpose

Coronary Occlusion

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NovaCross

About this trial

This is an interventional treatment trial for Coronary Occlusion

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Little Rock Medical Center
Nyph/Cumc
York Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NovaCross

Arm Description

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.

Outcomes

Primary Outcome Measures

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)).

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

Secondary Outcome Measures

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

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

Outcome Measure - Effective micro-catheter crossability

The effectiveness of the extendable portion in intra-CTO microcatheter crossability

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

Safety Measure - Myocardial Infraction (MI) rate

Rate of MI events, as defined according to the SCAI and 3rd universal definitions.

Full Information

NCT ID

NCT03719014

First Posted

October 23, 2018

Last Updated

November 4, 2018

Sponsor

Nitiloop Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03719014

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 2018 (Anticipated)

Primary Completion Date

April 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nitiloop Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Occlusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NovaCross

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

NovaCross

Intervention Description

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.

Primary Outcome Measure Information:

Title

Primary Safety Measure - Rate of in-hospital MACE events

Description

Defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).

Time Frame

up to 30 days

Title

Primary Outcome Measure - Intra-procedural technical succees

Description

Time Frame

Intra-procedure

Secondary Outcome Measure Information:

Title

Outcome Measure - Rate of procedure success

Description

Time Frame

Procedure

Title

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

Description

The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO

Time Frame

Procedure

Title

Outcome Measure - Effective micro-catheter crossability

Description

The effectiveness of the extendable portion in intra-CTO microcatheter crossability

Time Frame

Procedure

Title

Outcome Measure - Ease of Use

Description

Operator's ability to visualize the NoveCross micro-catheter throughout the procedure, as well as to assess the ease of use of the NovaCross

Time Frame

Procedure

Title

Safety Measure - Myocardial Infraction (MI) rate

Description

Rate of MI events, as defined according to the SCAI and 3rd universal definitions.

Time Frame

up to 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maya Shick

Phone

+972523355442

maya@nitiloop.com

First Name & Middle Initial & Last Name or Official Title & Degree

Itamar Haran

Phone

+972549985610

itamar@nitiloop.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon Walsh, MD

Organizational Affiliation

Belfast Health and Social Care Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Little Rock Medical Center

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristin Miller

Phone

501-257-5893

kristin.miller@va.gov

First Name & Middle Initial & Last Name & Degree

Barry Uretsky, MD

Facility Name

Nyph/Cumc

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kate Dalton

keb2114@cumc.columbia.edu

First Name & Middle Initial & Last Name & Degree

Dimitrios Kermpaliotis, MD

Facility Name

York Hospital

City

York

State/Province

Pennsylvania

ZIP/Postal Code

17403

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Lake

Phone

717-851-5153

slake@wellspan.org

First Name & Middle Initial & Last Name & Degree

William Nicholson, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs