Peripheral Arterial Disease
Conditions
Brief summary
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
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: 1. Fluoroscopy alone 2. 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.
Interventions
PROCEDURENavigation
Navigation of a balloon catheter using two navigation methods (1-Fluoroscopy only; 2- Fluoroscopy + CPS).
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of radiation | Changes from time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over 2 hours. | Medical radiation exposure for each balloon positioning |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose area product (DAP) | DAP change from when balloon leaves the sheath to final alignment with anatomical landmark assessed every 15 minutes over a 2 hours time frame. | Total amount of radiation delivered to the patient |
| Success or no-success in balloon navigation | Determined every 15 minutes over a 2 hours time frame. | Physician assessment of balloon navigation and center alignment with an anatomical landmark. |
| Time duration | From time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over a 2 hours time frame. | Procedure time for each balloon catheter positioning. |
| Distance measurements | At end of procedure | Distance between the center of balloon aligned with anatomical landmark and the two radiopaque balloon markers. |
| Number of adverse events. | At end of procedure | Adverse event count |
| Volume of contrast required to get the balloon to the anatomical landmark. | 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. | Volume used |
Countries
Canada
Outcome results
None listed