Clinical trial NCT04085614: Dynamic Coronary Roadmap for Contrast Reduction
Official title: Dynamic Coronary Roadmap for Contrast Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2019-09-11
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume
timeFrame: During Percutaneous Coronary Intervention (PCI) procedure
Secondary outcomes:
measure: Number of Angiograms
timeFrame: During Percutaneous Coronary Intervention (PCI) procedure
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi Saint-Joseph
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Madrid
country: Spain
facility: San Carlos Hospital
city: Madrid
country: Spain
facility: Fuenlabrada University Hospital
Study officials:
affiliation: San Carlos Hospital Madrid
name: Javier Escaned, MD
role: PRINCIPAL_INVESTIGATOR
References: