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

Heinrich-Heine University, Duesseldorf

Status: Unknown

Conditions: Coronary Disease

Treatments: Device: PCI Suite Software; Other: conventional PCI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03074721

16-022

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hemodynamically relevant type A or B lesion

Exclusion criteria

• hemodynamically relevant type C lesion
• NSTEMI/STEMI
• declined to participate

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

PCI with PCI Suite Software

Other group

Treatment:

Device: PCI Suite Software

conventional PCI

Other group

Treatment:

Other: conventional PCI