PCI Suite: Road Map Fusion Imaging in Coronary Diagnostics and Therapy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Amount of contrast medium
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •hemodynamically relevant type A or B lesion
Exclusion Criteria
- •hemodynamically relevant type C lesion
- •NSTEMI/STEMI
- •declined to participate
Outcomes
Primary Outcomes
Amount of contrast medium
Time Frame: Baseline
Determination during PCI
Secondary Outcomes
- Major adverse cardiac and cerebrovascular events(Baseline, after 6 months, after 12 months)
- Procedural success(Baseline)
- Procedure duration(Baseline)
- area dosage product(Baseline)