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

NCT01978860 | Completed

• 2 other identifiers: NT-C200-02 Rev 01HTA6696
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Maneuverability of the NovaCross ™ up to the occlusion and safe withdrawal

  During Procedure

Study Arms (1)

NovaCross, CTO

EXPERIMENTAL

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

Interventions

NovaCross, CTO DEVICE

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.

NovaCross, CTO

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Suitable candidate for non-emergent, coronary angioplasty
• 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:
• Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days;
• Satisfactory distal vessel visualization
• CTO should be amenable to percutaneous treatment and must be located in a coronary vessel with a reference diameter of at least 2 millimeters.
• CTO refractory to a minimum of 10 minutes of conventional guide wire attempt.
• Body Mass Index (BMI) \< 40
• 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.

You may not qualify if:

• \. Patient unable to give informed consent. 2. Current participation in another study with any investigational drug or device.
• \. 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.
• \. 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 )
• \. Severe electrolyte imbalance 16. Congestive heart failure \[New York Heart Association (NYHA) Class III\\IV\] ,CSA Class IV.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Chanan Schneider: lead
• Clinical Research Consultants, Inc.: collaborator

Study Sites (1)

Hadasa Ei Karem

Jerusalem, Israel, Israel

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Chaim - Lotan, MD

  Hadassah Ein Karem, Jerusalem Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: COO

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: November 8, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

IL (1)