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

Coronary Occlusion Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03719014
• Other study ID #: NT-CLP-01 Cohort B
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: December 2019

Study information

• Verified date: October 2018
• Source: Nitiloop Ltd.
• Contact: Maya Shick
• Phone: +972523355442
• Email: maya[@]nitiloop.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Occlusion

Intervention

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.

Locations

Country	Name	City	State
United States	Little Rock Medical Center	Little Rock	Arkansas
United States	Nyph/Cumc	New York	New York
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Nitiloop Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 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
Secondary	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
Secondary	Outcome Measure - Effective micro-catheter crossability	The effectiveness of the extendable portion in intra-CTO microcatheter crossability	Procedure
Secondary	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
Secondary	Safety Measure - Myocardial Infraction (MI) rate	Rate of MI events, as defined according to the SCAI and 3rd universal definitions.	up to 30 days