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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.
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:
The order of the navigation method (method 1 then method 2 or vice versa) will be determine arbitrarily determined for each subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main | Each subject in this group will be its own control for the two navigation methods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigation | Procedure | Navigation of a balloon catheter using two navigation methods (1-Fluoroscopy only; 2- Fluoroscopy + CPS). |
|
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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This is a prospective single-center, acute data collection study in 12 patients suffering from a peripheral arterial disease with an indication for an angioplasty procedure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institute | Montreal | Quebec | Canada |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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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 |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |