A Single Center Study to Evaluate the Safety of the NovaCross Microcatheter in Crossing Chronic Total Occlusions

NCT ID: NCT04862559

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-09-17

Brief Summary

This is an open label, single-center, prospective, pivotal study in which the investigational device, NovaCross™ micro-catheter, will be tested in up to 15 patients scheduled to undergo CTO-PCI using an anterograde approach.

Conditions

Chronic Total Occlusion

Study Design

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

Study Groups

NovaCross

Subjects in this arm are treated with the investigational device, NovaCross micro-cetheter, to facilitate the opening of a chronic total occlusion (CTO)

Group Type: EXPERIMENTAL

NovaCross

Intervention Type: DEVICE

A device that is intended to asisst interventional cardiologists during catheterization to cross and open coronary chronic total occlusions

Interventions

NovaCross

A device that is intended to asisst interventional cardiologists during catheterization to cross and open coronary chronic total occlusions

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult aged 25-80
• Patient understands and has signed the study informed consent form.
• Patient is a suitable candidate for non-emergent, coronary angioplasty
• Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration either by documentation or PI assessment Investigator) showing distal TIMI flow 0.
• Coronary angiography of CTO lesion reveals satisfactory distal vessel visualization
• CTO lesion is located in a coronary vessel with a reference diameter of at least 2 millimeters.
• CTO lesion is suitable for antegrade approach.
• Left ventricle ejection fraction > 25%
• Body Mass Index (BMI) < 40

Exclusion Criteria

• Patient unable to give informed consent.
• Patient is participating in another study with any investigational drug or device.
• Patient is known or suspected not to tolerate the contrast agent.
• Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO.
• Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
• Appearance of a fresh thrombus or intraluminal filling defects.
• Recent major cerebrovascular event (stroke or TIA within 30 days)
• Significant anemia (hemoglobin < 8.0 mg / dl)
• Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
• Recent myocardial infarction (MI) (within the past two weeks)
• Unwillingness or inability to comply with any protocol requirements
• Pregnancy or nursing

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

Sponsors

Nitiloop Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chanan Schneider, Mr.

Role: STUDY_DIRECTOR

Company Employee

Locations

Szpital Uniwersytecki w Krakowie

Krakow, , Poland

Countries

Poland

Other Identifiers

NT-CLP-02

Identifier Type: -

Identifier Source: org_study_id