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

Chronic Total Occlusion of Coronary Artery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978860
• Other study ID #: NT-C200-02 Rev 01
• Secondary ID: HTA6696
• Status: Completed
• Phase: N/A
• First received: October 23, 2013
• Last updated: October 6, 2015
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Nitiloop Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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.

Description:

To be filled later

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

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.

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadasa Ei Karem	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Chanan Schneider	Clinical Research Consultants, Inc.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes