Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap; Device: Percutaneous Coronary Intervention (PCI) 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

• Study Type: Interventional
• Enrollment (Actual): 371
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Eshuis, PhD; Phone Number: +31628739280; Email: peter.g.eshuis@philips.com

Study Locations

• Belgium
  • Charleroi, Belgium, 6060
    • Grand Hôpital de Charleroi Saint-Joseph
• Israel
  • Jerusalem, Israel
    • Hadassah Medical Center
• Spain
  • Madrid, Spain, 28040
    • San Carlos Hospital
  • Madrid, Spain
    • Fuenlabrada University Hospital
• United States
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NYPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynamic Coronary Roadmap group; Patients will be treated via standard of care for Percutaneous Coronary Intervention (PCI) with navigation support of Dynamic Coronary Roadmap.	Device: Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap; Standard of care Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap
Active Comparator: Control group; Patients will be treated via standard of care for Percutaneous Coronary Intervention (PCI) without navigation support of Dynamic Coronary Roadmap.	Device: Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap; Standard of care Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume	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).	During Percutaneous Coronary Intervention (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 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).	During Percutaneous Coronary Intervention (PCI) procedure

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Principal Investigator: Javier Escaned, MD, San Carlos Hospital Madrid

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): February 9, 2023
• Study Completion (Actual): February 9, 2023

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: XCY612-130576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No