Contrast Volume Reduction During PCI With the Use of a New Assisting Software Package
NCT ID: NCT02927990
Last Updated: 2024-12-06
Study Results
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View full resultsBasic Information
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TERMINATED
80 participants
OBSERVATIONAL
2017-12-15
2019-06-30
Brief Summary
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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 Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study group
Percutaneous coronary interventions with additional imaging provided by the new software package
Percutaneous Coronary Intervention
Percutaneous Coronary Intervention according to standard of care
Control group
Percutaneous coronary interventions without the new software package
Percutaneous Coronary Intervention
Percutaneous Coronary Intervention according to standard of care
Interventions
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Percutaneous Coronary Intervention
Percutaneous Coronary Intervention according to standard of care
Eligibility Criteria
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Inclusion Criteria
* Subject 18 years of age or older, or of legal age to give informed consent per state or national law.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Philips Clinical & Medical Affairs Global
INDUSTRY
Responsible Party
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Principal Investigators
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Manish Parikh, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University Medical Center/NYPH
Locations
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Columbia University Medical Center/NYPH
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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XCY607-130198
Identifier Type: -
Identifier Source: org_study_id