Cardiac Positioning System in Peripheral Angioplasty Procedure. (MDG-Periph)

Fluoroscopy vs Cardiac Positioning System Comparison to Assist the Navigation and Positioning of a Balloon Catheter in a Peripheral Artery During an Angioplasty Procedure

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Navigation

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 Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Montreal Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main; Each subject in this group will be its own control for the two navigation methods.	Procedure: Navigation; Navigation of a balloon catheter using two navigation methods (1-Fluoroscopy only; 2- Fluoroscopy + CPS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
Distance measurements	Distance between the center of balloon aligned with anatomical landmark and the two radiopaque balloon markers.	At end of procedure
Number of adverse events.	Adverse event count	At end of procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2019
• Primary Completion (Actual): May 10, 2020
• Study Completion (Actual): June 9, 2020

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 10252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No