Coronary Disease
Conditions
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.
Interventions
DEVICEPCI Suite Software
PCI with PCI Suite Software
OTHERconventional PCI
conventional PCI without PCI Software
Sponsors
Philips Medical Systems
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* hemodynamically relevant type A or B lesion
Exclusion criteria
* hemodynamically relevant type C lesion * NSTEMI/STEMI * declined to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of contrast medium | Baseline | Determination during PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac and cerebrovascular events | 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 |
| Procedural success | Baseline | Defined by an open target vessel with a maximum of 20% residual stenosis and TIMI III flow |
| Procedure duration | Baseline | Determination of duration of PCI |
| area dosage product | Baseline | Determination during PCI |
Countries
Germany
Contacts
Primary ContactTobias Zeus, MD
Backup ContactRabea Wagstaff, M.A.
Outcome results
None listed