Cardiac Positioning System in Peripheral Angioplasty Procedure.

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Procedure: Navigation

• Registration Number: NCT03585387
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-29
• Study First Posted: 2018-07-13
• Study Start: 2019-02-27
• Status Verified: 2019-07
• Primary Completion: 2020-05-10
• Study Completion: 2020-06-09
• Last Update Submitted: 2020-06-09
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Main	Navigation	Each subject in this group will be its own control for the two navigation methods.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of adverse events.	At end of procedure	Adverse event count
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
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.
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.
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.

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montréal, Quebec, Canada