Supplemental 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, Supplemental 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: Completed

Administrative data

• NCT number: NCT03717675
• Other study ID #: NT-CLP-03
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: December 2019
• Source: Nitiloop Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 1, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Occlusion

Intervention

Device:
• NovaCross™ Chronic Total Occlusion micro-catheter
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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tikva
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie	Kraków
United Kingdom	Belfast City Hospital	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
Nitiloop Ltd.

Countries where clinical trial is conducted

Israel,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)).	until discharge or 30 days, the sooner of the two
Primary	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	during the procedure
Secondary	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	during the procedure
Secondary	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	during the procedure
Secondary	Crossability	The effectiveness of the extendable portion in intra-CTO microcatheter crossability	during the procedure
Secondary	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	during the procedure
Secondary	Myocardial Infraction (MI) Rate	In hospital MI rate	up to 30 days
Secondary	Device Related Adverse Events	Device-related perforation at the site of target coronary lesion and/or its proximal reference segment	up to 30 days