Clinical trial NCT03719014: Cohort B of the Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter
Official title: A Prospective, Multi-Center, Non-randomized, Single Arm, Open Label, Pivotal 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: UNKNOWN
Phase: NA
Conditions: Coronary Occlusion
Lead sponsor: Nitiloop Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-25
Enrollment: 60
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
Intervention model description: This is an open label, multi-center, prospective, supplemental study in which the device, NovaCross™ CTO micro-catheter, will be tested in up to 60 patients scheduled to undergo CTO-PCI using an anterograde approach
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.
* Elevated CK-MB or troponin at baseline
* Patient is known or suspected not to tolerate the contrast agent
* Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion
* Appearance of a fresh thrombus or intraluminal filling defects
* Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor)
* Cardiac intervention within 4 weeks of the procedure
* Severe renal insufficiency with eGFR\<30 ml/min/1.72 m2
* Congestive heart failure \[New York Heart Association (NYHA) Class III\\IV\] CSA Class IV
* Life expectancy \< 2 years due to other illnesses
* 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 Measure - Rate of in-hospital MACE events
timeFrame: up to 30 days
measure: Primary Outcome Measure - Intra-procedural technical succees
timeFrame: Intra-procedure
Secondary outcomes:
measure: Outcome Measure - Rate of procedure success
timeFrame: Procedure
measure: Outcome Measure - Technical adaptation of the Micro-catheter to the guidewire
timeFrame: Procedure
measure: Outcome Measure - Effective micro-catheter crossability
timeFrame: Procedure
measure: Outcome Measure - Ease of Use
timeFrame: Procedure
measure: Safety Measure - Myocardial Infraction (MI) rate
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock Medical Center
state: Arkansas
city: New York
country: United States
facility: Nyph/Cumc
state: New York
city: York
country: United States
facility: York Hospital
state: Pennsylvania
Study officials:
affiliation: Belfast Health and Social Care Trust
name: Simon Walsh, MD
role: PRINCIPAL_INVESTIGATOR
References: