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NCT04085614 · ClinicalTrials.gov registry record · NA

Dynamic Coronary Roadmap for Contrast Reduction

A NA study, sponsored by Philips Clinical & Medical Affairs Global.

Completed
Registry status
NA
Development phase
371
Enrollment target

NCT04085614: Completed NA study, sponsored by Philips Clinical & Medical Affairs Global.

NCT04085614 is a NA study that has completed, run by Philips Clinical & Medical Affairs Global. The registered enrollment target is 371 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04085614, a NA study, has completed, sponsored by Philips Clinical & Medical Affairs Global.

COMPLETED
Registry status
NA
Development phase
371 participants
Enrollment target

Study 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.

Primary Outcome

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).

Interventions

  • DEVICE Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap
  • DEVICE Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap

Trial Details

FieldValue
Enrollment Target 371 participants
Start Date 2019-10-01
Est. Completion 2023-02-09
Phase NA

What the finished NCT04085614 record still lists

NCT04085614 is an interventional study that assigns participants to a tested intervention. The registered 371 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 2 interventions - of which Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap is the first listed.

NCT04085614 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04085614 about?

NCT04085614 is a clinical study titled "Dynamic Coronary Roadmap for Contrast Reduction". 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 i...

What is the current status of trial NCT04085614?

This trial is currently completed. It is a NA study. The enrollment target is 371 participants. The study started on 2019-10-01. Estimated completion is 2023-02-09.

What interventions are being tested in trial NCT04085614?

The interventions under investigation include: Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap (DEVICE), Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap (DEVICE).

Who is sponsoring clinical trial NCT04085614?

This trial is sponsored by Philips Clinical & Medical Affairs Global, which has 45 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04085614's enrollment target sits among peer trials

371 281st of 2000 higher than 1,720 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04085614, the US trial registry maintained by the National Library of Medicine. NCT04085614 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.