Clinical trial NCT03717675: Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Occlusion
Lead sponsor: Nitiloop Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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)

Primary outcomes:
measure: Primary Safety Endpoint - Rate of In hospital MACE events
timeFrame: until discharge or 30 days, the sooner of the two
measure: Primary Efficacy Endpoint - Intra-procedural technical success
timeFrame: during the procedure
Secondary outcomes:
measure: Rate of Lesion Crossing
timeFrame: during the procedure
measure: Guidewire Facilitation and rate of successful penetration to the CTO
timeFrame: during the procedure
measure: Crossability
timeFrame: during the procedure
measure: Investigator visualization and ease of use
timeFrame: during the procedure
measure: Myocardial Infraction (MI) Rate
timeFrame: up to 30 days
measure: Device Related Adverse Events
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Kraków
country: Poland
facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
Study officials:
affiliation: Belfast Health and Social Care Trust
name: Simon Walsh, MD
role: PRINCIPAL_INVESTIGATOR
References: