Cardiac Positioning System in Peripheral Angioplasty Procedure.

Abbott Medical Devices12 enrolled

Overview

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: 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

NavigationPROCEDURE

Navigation of a balloon catheter using two navigation methods (1-Fluoroscopy only; 2- Fluoroscopy + CPS).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Montreal Heart Institute

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Time of radiation

Medical radiation exposure for each balloon positioning

Time frame: Changes from time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over 2 hours.

Secondary Outcomes

Time duration

Procedure time for each balloon catheter positioning.

Time frame: 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)

Total amount of radiation delivered to the patient

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.

Success or no-success in balloon navigation

Physician assessment of balloon navigation and center alignment with an anatomical landmark.

Time frame: Determined every 15 minutes over a 2 hours time frame.

Volume of contrast required to get the balloon to the anatomical landmark.

Volume used

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.

Distance measurements

Distance between the center of balloon aligned with anatomical landmark and the two radiopaque balloon markers.

Time frame: At end of procedure

Number of adverse events.

Adverse event count

Data from ClinicalTrials.gov

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