CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 371 enrolled
Drug / intervention
Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04085614
NCT04085614N/ACompleted
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Dynamic Coronary Roadmap for Contrast Reduction

Philips Clinical & Medical Affairs Global·interventional·Posted Sep 11, 2019·Updated Jan 8, 2024

In Brief

A clinical study evaluating Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap and Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap for Coronary Artery Disease. Completed, enrolled 371 participants across 6 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesBelgium, Israel, Spain, United States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 11, 2019
Enrollment StartOct 1, 2019
Primary CompletionFeb 9, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.8 years ago

Interventions

Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmapdevice

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

Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmapdevice

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