PCI Suite: Road Map Fusion Imaging in Coronary Diagnostics and Therapy
PCI Suite
1 other identifier
interventional
130
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2017
CompletedFirst Posted
Study publicly available on registry
March 9, 2017
CompletedStudy Start
First participant enrolled
April 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 7, 2020
February 1, 2020
4.6 years
February 13, 2017
February 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of contrast medium
Determination during PCI
Baseline
Secondary Outcomes (4)
Major adverse cardiac and cerebrovascular events
Baseline, after 6 months, after 12 months
Procedural success
Baseline
Procedure duration
Baseline
area dosage product
Baseline
Study Arms (2)
PCI with PCI Suite Software
OTHERconventional PCI
OTHERInterventions
Eligibility Criteria
You may qualify if:
- hemodynamically relevant type A or B lesion
You may not qualify if:
- hemodynamically relevant type C lesion
- NSTEMI/STEMI
- declined to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heinrich-Heine University, Duesseldorflead
- Philips Medical Systemscollaborator
Study Sites (1)
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225, Germany
Related Publications (1)
Quast C, Phinicarides R, Afzal S, Veulemans V, Klein K, Berisha N, Leuders P, Erkens R, Jung C, Bonner F, Kelm M, Polzin A, Zeus T. Roadmap fusion imaging in percutaneous coronary intervention reduces contrast medium exposure irrespective of investigator's experience level. J Invasive Cardiol. 2024 Jan;36(1). doi: 10.25270/jic/23.00203.
PMID: 38224296DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tobias Zeus, MD
Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2017
First Posted
March 9, 2017
Study Start
April 24, 2017
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
February 7, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share