Cardiac Positioning System in Peripheral Angioplasty Procedure.

Study Overview
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Brief Summary
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This clinical investigation is intended to evaluate the ability of a magnetic cardiac positioning system to decrease medical radiation exposure on a peripheral angioplasty procedure in patients with a peripheral artery stenosis.

Detailed Description
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The present study aims at addressing the fluoroscopy exposure time concern among physicians by proposing a new methodology that capitalizes on the cardiac positioning system (CPS) to reach near-zero fluoroscopy time for interventional cardiologists. Intracoronary navigation of balloon catheter toward an anatomical landmark will be done with two navigation method: Fluoroscopy alone Fluoroscopy + CPS combination. The order of the navigation method (method 1 then method 2 or vice versa) will be determine arbitrarily determined for each subject.

Official Title
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Fluoroscopy vs Cardiac Positioning System Comparison to Assist the Navigation and Positioning of a Balloon Catheter in a Peripheral Artery During an Angioplasty Procedure

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: Navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age; Scheduled for clinically indicated or contemplated percutaneous transluminal angioplasty or stenting of an peripheral artery; Able to provide informed consent for study participation and willing and able to comply with the Clinical Investigational Plan described evaluation. Exclusion Criteria: Pregnant women or women planning to be pregnant during the study. Patients currently participating in another clinical study Patients with a thrombophilia Patients with critical limb ischemia Patients with unstable clinical condition or conditions limiting life expectancy that, in the opinion of the Study Investigator, excludes the participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main<br>Each subject in this group will be its own control for the two navigation methods. | Procedure: Navigation<br>* Navigation of a balloon catheter using two navigation methods (1-Fluoroscopy only; 2- Fluoroscopy + CPS).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of radiation | Medical radiation exposure for each balloon positioning | Changes from time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over 2 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time duration | Procedure time for each balloon catheter positioning. | From time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over a 2 hours time frame. | 
| Dose area product (DAP) | Total amount of radiation delivered to the patient | DAP change from when balloon leaves the sheath to final alignment with anatomical landmark assessed every 15 minutes over a 2 hours time frame. | 
| Success or no-success in balloon navigation | Physician assessment of balloon navigation and center alignment with an anatomical landmark. | Determined every 15 minutes over a 2 hours time frame. | 
| Volume of contrast required to get the balloon to the anatomical landmark. | Volume used | Change of volume of contrast from when balloon leaves the sheath to final alignment with anatomical landmark assessed every 15 minutes over a 2 hours time frame. | 
| Distance measurements | Distance between the center of balloon aligned with anatomical landmark and the two radiopaque balloon markers. | At end of procedure | 
| Number of adverse events. | Adverse event count | At end of procedure |