Clinical Trial: Contrast Volume Reduction During PCI With the Use of a New Assisting Software Package

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Contrast Volume Reduction During Percutaneous Coronary Interventions With the Use of a New Assisting Software Package

Brief Summary:

The new software package is intended to assist the physician in imaging the coronaries during percutaneous coronary interventions.

This study investigates the amount of contrast used during percutaneous coronary interventions with the aid of the new software package.

The results of the study will be compared with control group data (before the new software package was installed or after it was removed) to define a possible contrast reduction.


Detailed Summary:
Sponsor: Philips Healthcare

Current Primary Outcome: Amount [mL] of iodenated contrast media administered during Percutaneous Coronary Intervention [ Time Frame: Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cumulative Dose Area Product (DAP) of Percutaneous Coronary Intervention [ Time Frame: DAP [mGycm^2] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. ]
  • Cumulative Air-Kerma (AK) of percutaneous coronary intervention [ Time Frame: AK [mGy] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. ]
  • Total fluoroscopy time of percutaneous coronary intervention [ Time Frame: Fluoroscopy time [seconds] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. ]
  • Procedure efficiency [ Time Frame: Patients will be followed from start of interventional procedure (vascular access obtained) until end of the procedure (vascular closure), ranging between 30 minutes and a few hours. ]

    The endpoint is procedural timing:

    • time from start of procedure (wire introduced into the coronary)
    • end of procedure (start of vascular closure)
    • time until wire placed in distal coronary bed for purpose of intervention
    • time of first stent placement


Original Secondary Outcome: Same as current

Information By: Philips Healthcare

Dates:
Date Received: September 23, 2016
Date Started: June 1, 2017
Date Completion: November 1, 2017
Last Updated: April 20, 2017
Last Verified: April 2017