A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter

A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter in (CTO) Coronary Lesions

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.

Study Overview

• Status: Completed
• Conditions: Chronic Total Occlusion of Coronary Artery
• Intervention / Treatment: Device: NovaCross, CTO

Detailed Description

To be filled later

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadasa Ei Karem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NovaCross, CTO; 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.	Device: NovaCross, CTO; evaluate the safety and performance of the NovaCross™ micro-catheter in respect to providing additional guidewire support that is expected to allow easier crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lack of device related major adverse event	. 30-day Lack of device-related Major Adverse Cardiac Event Rate (MACE) at the site of target coronary lesion and/or its proximal reference segment. Time Frame:	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maneuverability of the NovaCross ™ up to the occlusion and safe withdrawal	Maneuverability of the NovaCross ™ up to the occlusion and safe withdrawal.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% and restoring antegrade TIMI 3 flow.	During Procedure

Collaborators and Investigators

• Sponsor: Chanan Schneider
• Collaborators: Clinical Research Consultants, Inc.
• Investigators: Principal Investigator: Chaim - Lotan, MD, Hadassah Ein Karem, Jerusalem Israel

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 23, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Estimate): October 7, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: CABG Coronary artery bypass grafting; CTO Chronic Total Occlusion; PCI Percutaneous coronary intervention; MACE Major adverse cardiovascular event(s); MI Myocardial infarction
• Other Study ID Numbers: NT-C200-02 Rev 01; HTA6696 (Other Identifier: Israeli Ministry of Health Department)