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NCT Number: NCT03717675

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

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.

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Key information

Conditions

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

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rabin Medical Center, Petah Tikva, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. 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)

Treatment and study plan

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.

Primary outcomes

  1. Primary Safety Endpoint - Rate of In hospital MACE events

    Time frame: 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)).

  2. Primary Efficacy Endpoint - Intra-procedural technical success

    Time frame: 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

Secondary outcomes

  1. Rate of Lesion Crossing

    Time frame: 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

  2. Guidewire Facilitation and rate of successful penetration to the CTO

    Time frame: during the procedure

    The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO

  3. Crossability

    Time frame: during the procedure

    The effectiveness of the extendable portion in intra-CTO microcatheter crossability

  4. Investigator visualization and ease of use

    Time frame: during the procedure

    The ability to have full visualization of the NovaCross during the CTO procedure and assessing the usability of the device

  5. Myocardial Infraction (MI) Rate

    Time frame: up to 30 days

    In hospital MI rate

  6. Device Related Adverse Events

    Time frame: up to 30 days

    Device-related perforation at the site of target coronary lesion and/or its proximal reference segment

Sponsors and collaborators

Lead sponsor

Nitiloop Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 24, 2018
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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