NCT03074721

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	PCI Suite Software	PCI with PCI Suite Software
OTHER	conventional PCI	conventional PCI without PCI Software

Timeline

• Start date: 2017-04-24
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2017-03-09
• Last updated: 2020-02-07

Locations

1 site across 1 country: Germany