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Completed

NCT Number: NCT03585387

Cardiac Positioning System in Peripheral 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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal Heart Institute

Montreal, Quebec, Canada

About this study

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:

  • Fluoroscopy alone
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Navigation

Procedure

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

Primary outcomes

  1. Time of radiation

    Time frame: 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 outcomes

  1. Time duration

    Time frame: 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.

  2. Dose area product (DAP)

    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.

    Total amount of radiation delivered to the patient

  3. Success or no-success in balloon navigation

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

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

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

    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.

    Volume used

  5. Distance measurements

    Time frame: At end of procedure

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

  6. Number of adverse events.

    Time frame: At end of procedure

    Adverse event count

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study 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

Acronym: MDG-Periph

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 13, 2018
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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