Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast)

Philips

Status: Completed

Conditions: Coronary Artery Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04085614

XCY612-130576

Details and patient eligibility

About

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.

Full 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

Enrollment: 371 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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371 participants in 2 patient groups

Dynamic Coronary Roadmap group

Experimental group

Description:

Patients will be treated via standard of care for Percutaneous Coronary Intervention (PCI) with navigation support of Dynamic Coronary Roadmap.

Treatment:

Device: Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap

Control group

Active Comparator group

Description:

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

Treatment:

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