Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast)

January 5, 2024 updated by: Philips Clinical & Medical Affairs Global

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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).
During Percutaneous Coronary Intervention (PCI) procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
During Percutaneous Coronary Intervention (PCI) procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Investigators

  • Principal Investigator: Javier Escaned, MD, San Carlos Hospital Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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