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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717675
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Occlusion Device: NovaCross™ Chronic Total Occlusion micro-catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : July 17, 2019
Actual Study Completion Date : November 1, 2019

Arm Intervention/treatment
Experimental: Interventional
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
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717675


Locations
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Israel
Rabin Medical Center
Petach Tikva, Israel
Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Kraków, Poland
United Kingdom
Belfast City Hospital
Belfast, United Kingdom
Sponsors and Collaborators
Nitiloop Ltd.
Investigators
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Principal Investigator: Simon Walsh, MD Belfast Health and Social Care Trust

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Responsible Party: Nitiloop Ltd.
ClinicalTrials.gov Identifier: NCT03717675    
Other Study ID Numbers: NT-CLP-03
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Coronary Occlusion
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases