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

Not Applicable

• Conditions: Coronary Disease
• Interventions: Device: PCI Suite Software; Other: conventional PCI

• Registration Number: NCT03074721
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-09
• Study Start: 2017-04-24
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• hemodynamically relevant type A or B lesion

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCI with PCI Suite Software	PCI Suite Software	-
conventional PCI	conventional PCI	-

Primary Outcome Measures

Name	Time	Method
Amount of contrast medium	Baseline	Determination during PCI

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Dusseldorf, Germany