Dynamic Coronary Roadmap for Contrast Reduction

Coronary Artery Disease Clinical Trial

— DCR4Contrast  

Official title:

Dynamic Coronary Roadmap for Contrast Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085614
• Other study ID #: XCY612-130576
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: February 9, 2023

Study information

• Verified date: January 2024
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap
Standard of care Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap
• Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap
Standard of care Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap

Locations

Country	Name	City	State
Belgium	Grand Hôpital de Charleroi Saint-Joseph	Charleroi
Israel	Hadassah Medical Center	Jerusalem
Spain	Fuenlabrada University Hospital	Madrid
Spain	San Carlos Hospital	Madrid
United States	University of Colorado Hospital	Denver	Colorado
United States	Columbia University Medical Center/NYPH	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Countries where clinical trial is conducted

United States,  Belgium,  Israel,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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