Cardiac Positioning System in Peripheral Angioplasty Procedure. (MDG-Periph)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03585387|
Recruitment Status : Enrolling by invitation
First Posted : July 13, 2018
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment|
|Peripheral Arterial Disease||Procedure: Navigation|
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.
|Study Type :||Observational|
|Estimated Enrollment :||12 participants|
|Official Title:||Fluoroscopy vs Cardiac Positioning System Comparison to Assist the Navigation and Positioning of a Balloon Catheter in a Peripheral Artery During an Angioplasty Procedure|
|Actual Study Start Date :||February 27, 2019|
|Estimated Primary Completion Date :||May 10, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Each subject in this group will be its own control for the two navigation methods.
Navigation of a balloon catheter using two navigation methods (1-Fluoroscopy only; 2- Fluoroscopy + CPS).
- Time of radiation [ Time Frame: 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
- Time duration [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: At end of procedure ]Distance between the center of balloon aligned with anatomical landmark and the two radiopaque balloon markers.
- Number of adverse events. [ Time Frame: At end of procedure ]Adverse event count
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585387
|Montreal Heart Institute|
|Montréal, Quebec, Canada|