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

NCT03717675 | Completed FDA Device

• 1 other identifier: NT-CLP-03
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 3

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.

Conditions

Coronary Occlusion

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (6)

• Rate of Lesion Crossing

  during the procedure

• Guidewire Facilitation and rate of successful penetration to the CTO

  during the procedure

• Crossability

  during the procedure

• Investigator visualization and ease of use

  during the procedure

• Myocardial Infraction (MI) Rate

  up to 30 days

Study Arms (1)

Interventional

EXPERIMENTAL

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

Device: NovaCross™ Chronic Total Occlusion micro-catheter

Interventions

NovaCross™ Chronic Total Occlusion micro-catheter DEVICE

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.

Interventional

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• Nitiloop Ltd.: lead

Study Sites (3)

Rabin Medical Center

Petah Tikva, Israel

Location

Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, Poland

Location

Belfast City Hospital

Belfast, United Kingdom

Location

MeSH Terms

Conditions

Coronary Occlusion

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Simon Walsh, MD

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: October 24, 2018
• Study Start: October 1, 2018
• Primary Completion: July 17, 2019
• Study Completion: November 1, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-12

Locations

IL (1); PL (1); GB (1)