Dynamic Coronary Roadmap for Contrast Reduction

Study Overview
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Brief Summary
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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 PCI compared to the control group without Dynamic Coronary Roadmap.

Detailed Description
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Primary objective: • To assess whether using Dynamic Coronary Roadmap reduces the total iodinated contrast volume related to 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 PCI in the Dynamic Coronary Roadmap and control group

Official Title
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Dynamic Coronary Roadmap for Contrast Reduction

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: PCI with Dynamic Coronary Roadmap
* Device: PCI without Dynamic Coronary Roadmap


Participation Criteria
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Eligibility Criteria
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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 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 PCI with Optical Coherence Tomography (OCT) support Subject undergoing PCI with rotational or orbital atherectomy Subject with Chronic Kidney Disease (CKD) stage V (eGFR < 15 ml/min/1.73 m2) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic Coronary Roadmap group<br>Patients will be treated via standard of care for PCI with navigation support of Dynamic Coronary Roadmap. | Device: PCI with Dynamic Coronary Roadmap<br>* Standard of care PCI with Dynamic Coronary Roadmap<br>|
| Active Comparator: Control group<br>Patients will be treated via standard of care for PCI without navigation support of Dynamic Coronary Roadmap. | Device: PCI without Dynamic Coronary Roadmap<br>* Standard of care PCI without Dynamic Coronary Roadmap<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total PCI iodinated contrast volume | Average total undiluted iodinated contrast volume (in ml) used per PCI (from first positioning the interventional guiding catheter in stable coronary position till end of PCI procedure) measured by an automatic contrast injector. | During PCI procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of angiograms | Average total number of contrast enhanced cine angiographic X-ray runs (angiograms) per PCI (from first positioning the interventional guiding catheter in stable coronary position till end of PCI procedure) determined via visual assessment (e.g., on the Philips X-ray system) | During PCI procedure |