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PCI Suite: Road Map Fusion Imaging in Coronary Diagnostics and Therapy

NCT03074721 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2020-02-07

No results posted yet for this study

Summary

The PCI Suite is developed by Philips Medical Systems, a Philips Healthcare company. The proposed PCI Suite is a new software package which can be used during coronary interventions. The software package includes two sub-packages, known as StentBoost and Cardiac Roadmapping.

The patient will undergo standard of care medical treatment for his or her cardiac condition. During the procedure, the physician may make angiograms for diagnosis and as reference for device navigation as part of the standard care. These angiograms will be automatically processed in PCI Suite and displayed on fluoroscopy for navigation support. In case a balloon catheter is inserted into the coronary arteries, the physician may take cine images as part of the standard care. These images can be automatically enhanced in PCI Suite. The primary objective of this prospective, mono-center, randomized clinical trial is to evaluate the amount of contrast medium used during percutaneous coronary intervention.

Conditions

  • Coronary Disease

Interventions

DEVICE

PCI Suite Software

PCI with PCI Suite Software

OTHER

conventional PCI

conventional PCI without PCI Software

Sponsors & Collaborators

  • Philips Medical Systems

    collaborator INDUSTRY

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Tobias Zeus, MD · Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Germany

Study Locations

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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 NCT03074721 on ClinicalTrials.gov