Dynamic Coronary Roadmap for Contrast Reduction

Not Applicable

Completed

Interventions: Device: Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap
Device: Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap

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 provide a real-time and dynamic angiographic roadmap of coronary arteries. The angiographic roadmap is automatically generated from previously acquired coronary angiograms during the same procedure. Dynamic Coronary Roadmap overlays the angiographic roadmap on live 2D fluoroscopic images, thereby assisting the physician in navigating devices, e.g. (guide) wires, catheters, through the coronary arteries.

This is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial to assess whether using Dynamic Coronary Roadmap reduces the total iodinated contrast volume related to Percutaneous Coronary Intervention (PCI) compared to the control group without Dynamic Coronary Roadmap.

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 without Dynamic Coronary Roadmap.

Secondary objective:

• To assess the total number of contrast enhanced cine angiographic X-ray runs (angiograms) related to Percutaneous Coronary Intervention (PCI) in the Dynamic Coronary Roadmap and control group

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Dynamic Coronary Roadmap group	Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap	Patients will be treated via standard of care for Percutaneous Coronary Intervention (PCI) with navigation support of Dynamic Coronary Roadmap.
Control group	Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap	Patients will be treated via standard of care for Percutaneous Coronary Intervention (PCI) without navigation support of Dynamic Coronary Roadmap.

Primary Outcome Measures

Name	Time	Method
Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume	During Percutaneous Coronary Intervention (PCI) procedure	Average total undiluted contrast volume (in ml, measured by an automatic contrast injector) per Percutaneous Coronary Intervention (PCI), where the start of the PCI is marked by the moment the interventional guiding catheter is positioned in a stable coronary position and the end of the PCI is marked by time of the last PCI check exposure run (angiogram).

Secondary Outcome Measures

Name	Time	Method
Number of Angiograms	During Percutaneous Coronary Intervention (PCI) procedure	Average total number of contrast enhanced cine angiographic X-ray runs (angiograms) per Percutaneous Coronary Intervention (PCI) (from start of PCI marked by the moment the interventional guiding catheter is positioned in a stable coronary position till the end of the PCI marked by the time of the last PCI check exposure run, i.e., angiogram) determined via visual assessment (e.g., on the Philips X-ray system).

Locations (6): Grand Hôpital de Charleroi Saint-Joseph
🇧🇪
Charleroi, Belgium
Columbia University Medical Center/NYPH
🇺🇸
New York, New York, United States
Hadassah Medical Center
🇮🇱
Jerusalem, Israel
San Carlos Hospital
🇪🇸
Madrid, Spain
Fuenlabrada University Hospital
🇪🇸
Madrid, Spain
University of Colorado Hospital
🇺🇸
Denver, Colorado, United States