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

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Philips

Status

Terminated

Conditions

Coronary Occlusion
Coronary Stenosis

Treatments

Other: Percutaneous Coronary Intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT02927990
XCY607-130198

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject undergoing a percutaneous coronary intervention.
  • Subject 18 years of age or older, or of legal age to give informed consent per state or national law.

Exclusion criteria

  • Subject undergoing an emergency treatment
  • Primary angioplasty for acute ST segment elevation myocardial infarction.
  • Subject with contrast allergies
  • Subject with severe kidney disease (e-GFR < 40 by Modification of Diet in Renal Disease (MDRD)/Cockcroft Gault clearance formula and/or upon decision by investigator)
  • Subject participates in a potentially confounding drug or device trial during the course of the study.
  • Prisoners, people who cannot legally give consent, pregnant women and breastfeeding women.

Trial design

80 participants in 2 patient groups

Study group
Description:
Percutaneous coronary interventions with additional imaging provided by the new software package
Treatment:
Other: Percutaneous Coronary Intervention
Control group
Description:
Percutaneous coronary interventions without the new software package
Treatment:
Other: Percutaneous Coronary Intervention

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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