- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03074721
PCI Suite: Road Map Fusion Imaging in Coronary Diagnostics and Therapy (PCI Suite)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tobias Zeus, MD
- Phone Number: +492118118800
- Email: pruefer.kardiologie@med.uni-duesseldorf.de
Study Contact Backup
- Name: Rabea Wagstaff, M.A.
- Phone Number: +492118118914
- Email: rabea.wagstaff@med.uni-duesseldorf.de
Study Locations
-
-
-
Dusseldorf, Germany, 40225
- Recruiting
- Division of Cardiology, Pulmonary Disease and Vascular Medicine
-
Sub-Investigator:
- Florian Bönner, MD
-
Sub-Investigator:
- Christian Jung, MD
-
Contact:
- Tobias Zeus, MD
-
Principal Investigator:
- Tobias Zeus, MD
-
Sub-Investigator:
- Laura Kleinebrecht, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- hemodynamically relevant type A or B lesion
Exclusion Criteria:
- hemodynamically relevant type C lesion
- NSTEMI/STEMI
- declined to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: PCI with PCI Suite Software
|
PCI with PCI Suite Software
|
Other: conventional PCI
|
conventional PCI without PCI Software
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of contrast medium
Time Frame: Baseline
|
Determination during PCI
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiac and cerebrovascular events
Time Frame: Baseline, after 6 months, after 12 months
|
Major adverse cardiac and cerebrovascular events (MACCE) are defined as occurence of myocardial ischemia, stroke, acute stent thrombosis, major bleeding
|
Baseline, after 6 months, after 12 months
|
Procedural success
Time Frame: Baseline
|
Defined by an open target vessel with a maximum of 20% residual stenosis and TIMI III flow
|
Baseline
|
Procedure duration
Time Frame: Baseline
|
Determination of duration of PCI
|
Baseline
|
area dosage product
Time Frame: Baseline
|
Determination during PCI
|
Baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tobias Zeus, MD, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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