Status:
COMPLETED
Dynamic Coronary Roadmap for Contrast Reduction
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Dynamic Coronary Roadmap is a commercially available product developed by Philips Medical Systems, a Philips Healthcare company. Dynamic Coronary Roadmap is a software medical device intended to p...
Detailed Description
Primary objective: • To assess whether using Dynamic Coronary Roadmap reduces the total iodinated contrast volume related to Percutaneous Coronary Intervention (PCI) compared to the control group wit...
Eligibility Criteria
Inclusion
- Subject is undergoing Percutaneous Coronary Intervention (PCI) with a degree of complexity that anticipates the need for more than 25ml of iodinated contrast volume
- Subject has signed informed consent
- Subject is 18 years of age or older, or of legal age to give informed consent per state or national law
Exclusion
- Subject undergoing emergency Percutaneous Coronary Intervention (PCI)
- Subject with ST-segment Elevation Myocardial Infarction (STEMI)
- Subject with Chronic Total Occlusion (CTO)
- Subject undergoing PCI for isolated ostial disease of Left Main Coronary Artery (LMCA) or Right Coronary Artery (RCA)
- Subject undergoing Percutaneous Coronary Intervention (PCI) with Optical Coherence Tomography (OCT) support
- Subject undergoing Percutaneous Coronary Intervention (PCI) with rotational or orbital atherectomy
- Subject with Chronic Kidney Disease (CKD) stage V (estimated Glomerular Filtration Rate (eGFR) \< 15 ml/min/1.73 m\^2)
- Subject with contrast allergy that cannot be adequately pre-medicated
- Subject participates in a potentially confounding drug or device trial during the course of the study.
- Subject is under 18 years of age, or pregnant woman, or breast feeding woman, or meets an exclusion criteria according to national law
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2023
Estimated Enrollment :
371 Patients enrolled
Trial Details
Trial ID
NCT04085614
Start Date
October 1 2019
End Date
February 9 2023
Last Update
January 8 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Hospital
Denver, Colorado, United States, 80045
2
Columbia University Medical Center/NYPH
New York, New York, United States, 10032
3
Grand Hôpital de Charleroi Saint-Joseph
Charleroi, Belgium, 6060
4
Hadassah Medical Center
Jerusalem, Israel