MDG-Periph: Cardiac Positioning System in Peripheral Angioplasty Procedure.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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Fluoroscopy alone
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Main Each subject in this group will be its own control for the two navigation methods. |
Procedure: Navigation
Navigation of a balloon catheter using two navigation methods (1-Fluoroscopy only; 2- Fluoroscopy + CPS).
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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At least 18 years of age;
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Scheduled for clinically indicated or contemplated percutaneous transluminal angioplasty or stenting of an peripheral artery;
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Able to provide informed consent for study participation and willing and able to comply with the Clinical Investigational Plan described evaluation.
Exclusion Criteria:
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Pregnant women or women planning to be pregnant during the study.
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Patients currently participating in another clinical study
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Patients with a thrombophilia
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Patients with critical limb ischemia
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Patients with unstable clinical condition or conditions limiting life expectancy that, in the opinion of the Study Investigator, excludes the participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montreal Heart Institute | Montréal | Quebec | Canada |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10252