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Dynamic Coronary Roadmap for Contrast Reduction

NCT04085614 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 371

Last updated 2024-01-08

Study results available
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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.

Conditions

Interventions

DEVICE

Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap

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

DEVICE

Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap

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

Sponsors & Collaborators

  • Philips Clinical & Medical Affairs Global

    lead INDUSTRY

Principal Investigators

  • Javier Escaned, MD · San Carlos Hospital Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2023-02-09
Completion
2023-02-09
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Israel
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04085614 on ClinicalTrials.gov