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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 : Completed
First Posted : July 13, 2018
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date June 19, 2018
First Posted Date July 13, 2018
Last Update Posted Date June 11, 2020
Actual Study Start Date February 27, 2019
Actual Primary Completion Date May 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 29, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 29, 2018)
  • 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.
  • 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
  • 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.
  • 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
  • Distance measurements [ Time Frame: At end of procedure ]
    Distance between the center of balloon aligned with anatomical landmark and the two radiopaque balloon markers.
  • Number of adverse events. [ Time Frame: At end of procedure ]
    Adverse event count
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiac Positioning System in Peripheral Angioplasty Procedure.
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Peripheral Arterial Disease
Intervention Procedure: Navigation
Navigation of a balloon catheter using two navigation methods (1-Fluoroscopy only; 2- Fluoroscopy + CPS).
Study Groups/Cohorts Main
Each subject in this group will be its own control for the two navigation methods.
Intervention: Procedure: Navigation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 29, 2018)
12
Original Estimated Enrollment Same as current
Actual Study Completion Date June 9, 2020
Actual Primary Completion Date May 10, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03585387
Other Study ID Numbers 10252
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators Not Provided
PRS Account Abbott Medical Devices
Verification Date July 2019