Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03585387
Recruitment Status : Enrolling by invitation
First Posted : July 13, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Peripheral Arterial Disease 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : May 10, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

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).




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585387


Locations
Layout table for location information
Canada, Quebec
Montreal Heart Institute
Montréal, Quebec, Canada
Sponsors and Collaborators
Abbott Medical Devices

Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03585387     History of Changes
Other Study ID Numbers: 10252
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases