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

Not Applicable

• Conditions: Coronary Occlusion
• Interventions: Device: NovaCross

• Registration Number: NCT03719014
• Lead Sponsor: Nitiloop Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Study Start: 2018-11
• Last Update Submitted: 2018-11-04
• Last Update Posted: 2018-11-06
• Primary Completion: 2019-04
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NovaCross	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.

Primary Outcome Measures

Name	Time	Method
Primary Safety Measure - Rate of in-hospital MACE events	up to 30 days	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-procedure	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

Name	Time	Method
Outcome Measure - Technical adaptation of the Micro-catheter to the guidewire	Procedure	The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO
Outcome Measure - Ease of Use	Procedure	Operator's ability to visualize the NoveCross micro-catheter throughout the procedure, as well as to assess the ease of use of the NovaCross
Outcome Measure - Rate of procedure success	Procedure	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 - Effective micro-catheter crossability	Procedure	The effectiveness of the extendable portion in intra-CTO microcatheter crossability
Safety Measure - Myocardial Infraction (MI) rate	up to 30 days	Rate of MI events, as defined according to the SCAI and 3rd universal definitions.

Trial Locations

Locations (3)

Little Rock Medical Center; 🇺🇸 Little Rock, Arkansas, United States

Nyph/Cumc; 🇺🇸 New York, New York, United States

York Hospital; 🇺🇸 York, Pennsylvania, United States