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

Not Applicable

Completed

• Conditions: Coronary Occlusion
• Interventions: Device: NovaCross™ Chronic Total Occlusion micro-catheter

• Registration Number: NCT03717675
• Lead Sponsor: Nitiloop Ltd.

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.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-21
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-24
• Primary Completion: 2019-07-17
• Study Completion: 2019-11-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Adult aged 25-80
2. Patient understands and has signed the study informed consent form
3. 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.
4. 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint - Intra-procedural technical success	during the procedure	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
Primary Safety Endpoint - Rate of In hospital MACE events	until discharge or 30 days, the sooner of the two	defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).

Secondary Outcome Measures

Name	Time	Method
Rate of Lesion Crossing	during the 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
Investigator visualization and ease of use	during the procedure	The ability to have full visualization of the NovaCross during the CTO procedure and assessing the usability of the device
Crossability	during the procedure	The effectiveness of the extendable portion in intra-CTO microcatheter crossability
Myocardial Infraction (MI) Rate	up to 30 days	In hospital MI rate
Device Related Adverse Events	up to 30 days	Device-related perforation at the site of target coronary lesion and/or its proximal reference segment
Guidewire Facilitation and rate of successful penetration to the CTO	during the procedure	The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO

Trial Locations

Locations (3)

Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie; 🇵🇱 Kraków, Poland

Belfast City Hospital; 🇬🇧 Belfast, United Kingdom

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel