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Completed

NCT Number: NCT04085614

Dynamic Coronary Roadmap for Contrast Reduction

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grand Hôpital de Charleroi Saint-Joseph, Charleroi, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap

Device

Standard of care Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap

Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap

Device

Standard of care Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap

Primary outcomes

  1. Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume

    Time frame: 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 outcomes

  1. Number of Angiograms

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Acronym: DCR4Contrast

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 11, 2019
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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