Clinical trial NCT01978860: A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter
Official title: A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter in (CTO) Coronary Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Total Occlusion of Coronary Artery
Keywords: CABG Coronary artery bypass grafting
CTO Chronic Total Occlusion
PCI Percutaneous coronary intervention
MACE Major adverse cardiovascular event(s)
MI Myocardial infarction
Lead sponsor: Nitiloop Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Clinical Research Consultants, Inc.
First posted: 2013-11-08
Enrollment: 2
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 is a prospective, non-randomized, first-in-man investigational study, to assess the safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™ micro-catheter during an interventional coronary angioplasty procedure and evaluating the CTO penetration rate.

Each study subject/patient will have a total of one (1) procedure performed for this study.

Detailed description: To be filled later

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.
4. Suitable candidate for non-emergent, coronary angioplasty
5. Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches with the following characteristics:

   1. Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days;
   2. Satisfactory distal vessel visualization
   3. CTO should be amenable to percutaneous treatment and must be located in a coronary vessel with a reference diameter of at least 2 millimeters.
   4. CTO refractory to a minimum of 10 minutes of conventional guide wire attempt.
6. Body Mass Index (BMI) \< 40
7. Left ventricle ejection fraction \> 25%

For the purpose of this trial, a CTO is defined as a 100% luminal narrowing without antegrade flow or with antegrade or retrograde filling through collateral vessels.

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Exclusion Criteria:

* 1. Patient unable to give informed consent. 2. Current participation in another study with any investigational drug or device.

  3. Patient is known or suspected not to tolerate the contrast agent. 4. Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO and in-stent CTOs.

  5. Intolerance to aspirin or Clopidogrel or Prasugrel or Ticagrelor medications 6. Appearance of a fresh thrombus or intraluminal filling defects. 7. Recent major cerebrovascular event (history of stroke or TIA within 1 month) 8. Cardiac intervention within 4 weeks of the procedure 9. Renal insufficiency (serum creatinine of \> 2.3mg/dl) 10. Active gastrointestinal bleeding 11. Active infection or fever that may be due to infection 12. Life expectancy \< 2 years due to other illnesses 13. Significant anemia (hemoglobin \< 8.0 mg / dl) 14. Severe uncontrolled systemic hypertension (\> 240 mmHg within 1 month of procedure )

  15. Severe electrolyte imbalance 16. Congestive heart failure \[New York Heart Association (NYHA) Class III\\IV\] ,CSA Class IV.

  17. Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) 18. Recent myocardial infarction (MI) (within the past two weeks) 19. Uncontrolled diabetes \>2 serum glucose concentrations of \>350 mg/dl within 7 days.

  20. Participation in another investigational protocol 21. Unwillingness or inability to comply with any protocol requirements 22. Pregnant or nursing 23. Extensive prior dissection from a coronary guidewire use 24. Drug abuse or alcoholism. 25. Patients under custodial care. 26. Bleeding diathesis or coagulation disorder; 27. Kawasaki's disease or other vasculitis.

Primary outcomes:
measure: lack of device related major adverse event
timeFrame: 30 days
Secondary outcomes:
measure: Maneuverability of the NovaCross ™ up to the occlusion and safe withdrawal
timeFrame: During Procedure
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadasa Ei Karem
Study officials:
affiliation: Hadassah Ein Karem, Jerusalem Israel
name: Chaim - Lotan, MD
role: PRINCIPAL_INVESTIGATOR
References: