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

Coronary Disease Clinical Trial

— PCI Suite  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03074721
• Other study ID #: 16-022
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: December 2021

Study information

• Verified date: February 2020
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Tobias Zeus, MD
• Phone: +492118118800
• Email: pruefer.kardiologie[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hemodynamically relevant type A or B lesion

Exclusion Criteria:

• hemodynamically relevant type C lesion

• NSTEMI/STEMI

• declined to participate

Related Conditions & MeSH terms

• Coronary Disease

Intervention

Device:
• PCI Suite Software
PCI with PCI Suite Software

Other:
• conventional PCI
conventional PCI without PCI Software

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Dusseldorf

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	Philips Medical Systems

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of contrast medium	Determination during PCI	Baseline
Secondary	Major adverse cardiac and cerebrovascular events	Major adverse cardiac and cerebrovascular events (MACCE) are defined as occurence of myocardial ischemia, stroke, acute stent thrombosis, major bleeding	Baseline, after 6 months, after 12 months
Secondary	Procedural success	Defined by an open target vessel with a maximum of 20% residual stenosis and TIMI III flow	Baseline
Secondary	Procedure duration	Determination of duration of PCI	Baseline
Secondary	area dosage product	Determination during PCI	Baseline