Clinical trial NCT03585387: Cardiac Positioning System in Peripheral Angioplasty Procedure.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2018-07-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time of radiation
timeFrame: Changes from time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over 2 hours.
Secondary outcomes:
measure: Time duration
timeFrame: From time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over a 2 hours time frame.
measure: Dose area product (DAP)
timeFrame: DAP change from when balloon leaves the sheath to final alignment with anatomical landmark assessed every 15 minutes over a 2 hours time frame.
measure: Success or no-success in balloon navigation
timeFrame: Determined every 15 minutes over a 2 hours time frame.
measure: Volume of contrast required to get the balloon to the anatomical landmark.
timeFrame: 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.
measure: Distance measurements
timeFrame: At end of procedure
measure: Number of adverse events.
timeFrame: At end of procedure
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
References: