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Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

Primary Purpose

Coronary Occlusion

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

NovaCross™ Chronic Total Occlusion micro-catheter

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:

1. Patient unable to give informed consent. 2. Elevated CK-MB or troponin at baseline 3. Patient is known or suspected not to tolerate the contrast agent 4. Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion 5. Appearance of a fresh thrombus or intraluminal filling defects 6. Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor) 7. Cardiac intervention within 4 weeks of the procedure 8. Severe renal insufficiency with eGFR<30 ml/min/1.72 m2 9. Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV 10. Life expectancy < 2 years due to other illnesses 11. 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

Rabin Medical Center
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Belfast City Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm Description

Interventional arm, where the NovaCross™ CTO micro-catheter will be placed in study subjects during the Total Occlusion opening procedure.

Outcomes

Primary Outcome Measures

Primary Safety Endpoint - 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 Efficacy Endpoint - 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

Rate of Lesion Crossing

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

Guidewire Facilitation and rate of successful penetration to the CTO

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

Crossability

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

Investigator visualization and ease of use

The ability to have full visualization of the NovaCross during the CTO procedure and assessing the usability of the device

Myocardial Infraction (MI) Rate

In hospital MI rate

Device Related Adverse Events

Device-related perforation at the site of target coronary lesion and/or its proximal reference segment

Full Information

NCT ID

NCT03717675

First Posted

October 21, 2018

Last Updated

December 2, 2019

Sponsor

Nitiloop Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03717675

Brief Title

Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

July 17, 2019 (Actual)

Study Completion Date

November 1, 2019 (Actual)

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

Data Monitoring Committee

5. Study Description

Brief Summary

This study will include up to 60 eligible male and female subjects. The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt. This study is an extension study of Nitiloop's Pivotal study.

Detailed Description

The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Interventional

Arm Type

Experimental

Arm Description

Interventional arm, where the NovaCross™ CTO micro-catheter will be placed in study subjects during the Total Occlusion opening procedure.

Intervention Type

Device

Intervention Name(s)

NovaCross™ Chronic Total Occlusion micro-catheter

Intervention Description

The NovaCross™ micro catheter 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 extendable segment. Investigators will use the NovaCross Micro catheter during a standard of care catheterization of patients diagnosed with coronary total occlusion.

Primary Outcome Measure Information:

Title

Primary Safety Endpoint - 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

until discharge or 30 days, the sooner of the two

Title

Primary Efficacy Endpoint - Intra-procedural technical success

Description

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

Time Frame

during the procedure

Secondary Outcome Measure Information:

Title

Rate of Lesion Crossing

Description

Time Frame

during the procedure

Title

Guidewire Facilitation and rate of successful penetration to the CTO

Description

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

Time Frame

during the procedure

Title

Crossability

Description

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

Time Frame

during the procedure

Title

Investigator visualization and ease of use

Description

The ability to have full visualization of the NovaCross during the CTO procedure and assessing the usability of the device

Time Frame

during the procedure

Title

Myocardial Infraction (MI) Rate

Description

In hospital MI rate

Time Frame

up to 30 days

Title

Device Related Adverse Events

Description

Device-related perforation at the site of target coronary lesion and/or its proximal reference segment

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: 1. Patient unable to give informed consent. 2. Elevated CK-MB or troponin at baseline 3. Patient is known or suspected not to tolerate the contrast agent 4. Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion 5. Appearance of a fresh thrombus or intraluminal filling defects 6. Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor) 7. Cardiac intervention within 4 weeks of the procedure 8. Severe renal insufficiency with eGFR<30 ml/min/1.72 m2 9. Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV 10. Life expectancy < 2 years due to other illnesses 11. 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)

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

Rabin Medical Center

City

Petach Tikva

Country

Israel

Facility Name

Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

City

Kraków

Country

Poland

Facility Name

Belfast City Hospital

City

Belfast

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

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