Cardiac Positioning System in Peripheral Angioplasty Procedure.

Peripheral Arterial Disease Clinical Trial

— MDG-Periph  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585387
• Other study ID #: 10252
• Status: Completed
• Start date: February 27, 2019
• Est. completion date: June 9, 2020

Study information

• Verified date: July 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 9, 2020
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of radiation	Medical radiation exposure for each balloon positioning	Changes from time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over 2 hours.
Secondary	Time duration	Procedure time for each balloon catheter positioning.	From time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over a 2 hours time frame.
Secondary	Dose area product (DAP)	Total amount of radiation delivered to the patient	DAP change from when balloon leaves the sheath to final alignment with anatomical landmark assessed every 15 minutes over a 2 hours time frame.
Secondary	Success or no-success in balloon navigation	Physician assessment of balloon navigation and center alignment with an anatomical landmark.	Determined every 15 minutes over a 2 hours time frame.
Secondary	Volume of contrast required to get the balloon to the anatomical landmark.	Volume used	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.
Secondary	Distance measurements	Distance between the center of balloon aligned with anatomical landmark and the two radiopaque balloon markers.	At end of procedure
Secondary	Number of adverse events.	Adverse event count	At end of procedure