Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter
Launched by NITILOOP LTD. · Oct 23, 2018
Trial Information
Current as of July 23, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility 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)
About Nitiloop Ltd.
Nitiloop Ltd. is a pioneering clinical trial sponsor dedicated to advancing innovative therapeutic solutions through rigorous research and development. With a focus on enhancing patient outcomes, Nitiloop Ltd. specializes in designing and conducting phase I to phase III clinical trials across various therapeutic areas. The company leverages cutting-edge technology and a streamlined approach to ensure efficient trial management, while adhering to the highest ethical standards and regulatory compliance. Committed to collaboration and transparency, Nitiloop Ltd. partners with healthcare professionals and institutions to facilitate the rapid translation of scientific discoveries into tangible healthcare advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Petach Tikva, , Israel
Belfast, , United Kingdom
Kraków, , Poland
Patients applied
Trial Officials
Simon Walsh, MD
Principal Investigator
Belfast Health and Social Care Trust
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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