PCI Suite: Road Map Fusion Imaging in Coronary Diagnostic... | NCT03074721

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

NCT03074721

Sponsor

Heinrich-Heine University, Duesseldorf

Status

Unknown status

Last Update Posted

Feb 7, 2020Actual

Enrollment

130Estimated

Phase

Not Applicable

Conditions

Coronary Disease

Interventions

PCI Suite Software
conventional PCI

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2017Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Feb 13, 2017

First Submission Date that Met QC Criteria

Mar 3, 2017

First Posted Date

Mar 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2020

Last Update Posted Date

Feb 7, 2020Actual

Name	Class
Philips Medical Systems	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PCI with PCI Suite Software	Other		Device: PCI Suite Software
conventional PCI	Other		Other: conventional PCI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PCI Suite Software	Device	PCI with PCI Suite Software	PCI with PCI Suite Software

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of contrast medium	Determination during PCI	Baseline

Secondary Outcomes

Measure	Description	Time Frame
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
Procedural success

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hemodynamically relevant type A or B lesion

Exclusion Criteria:

hemodynamically relevant type C lesion
NSTEMI/STEMI
declined to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tobias Zeus, MD	Contact	+492118118800		pruefer.kardiologie@med.uni-duesseldorf.de
Rabea Wagstaff, M.A.	Contact	+492118118914		rabea.wagstaff@med.uni-duesseldorf.de

Overall Officials

Name	Affiliation	Role
Tobias Zeus, MD	Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology, Pulmonary Disease and Vascular Medicine	Recruiting	Düsseldorf		40225	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38224296	Derived	Quast C, Phinicarides R, Afzal S, Veulemans V, Klein K, Berisha N, Leuders P, Erkens R, Jung C, Bonner F, Kelm M, Polzin A, Zeus T. Roadmap fusion imaging in percutaneous coronary intervention reduces contrast medium exposure irrespective of investigator's experience level. J Invasive Cardiol. 2024 Jan;36(1). doi: 10.25270/jic/23.00203.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases