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

NCT ID: NCT01978860

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-12-31

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

Conditions

Chronic Total Occlusion of Coronary Artery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NovaCross, CTO

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Research Consultants, Inc.

INDUSTRY

Sponsor Role: collaborator

Chanan Schneider

INDUSTRY

Sponsor Role: lead

Responsible Party

Chanan Schneider

COO

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chaim - Lotan, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Ein Karem, Jerusalem Israel

Locations

Hadasa Ei Karem

Jerusalem, Israel, Israel

Countries

Israel

Other Identifiers

HTA6696

Identifier Type: OTHER

Identifier Source: secondary_id

NT-C200-02 Rev 01

Identifier Type: -

Identifier Source: org_study_id