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

Primary Purpose

Coronary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PCI Suite Software
conventional PCI
Sponsored by
Heinrich-Heine University, Duesseldorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hemodynamically relevant type A or B lesion

Exclusion Criteria:

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

Sites / Locations

  • Division of Cardiology, Pulmonary Disease and Vascular MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

PCI with PCI Suite Software

conventional PCI

Arm Description

Outcomes

Primary Outcome Measures

Amount of contrast medium
Determination during PCI

Secondary Outcome Measures

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
Procedural success
Defined by an open target vessel with a maximum of 20% residual stenosis and TIMI III flow
Procedure duration
Determination of duration of PCI
area dosage product
Determination during PCI

Full Information

First Posted
February 13, 2017
Last Updated
February 6, 2020
Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
Philips Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT03074721
Brief Title
PCI Suite: Road Map Fusion Imaging in Coronary Diagnostics and Therapy
Acronym
PCI Suite
Official Title
PCI Suite: Road Map Fusion Imaging in Coronary Diagnostics and Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
Philips Medical Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCI with PCI Suite Software
Arm Type
Other
Arm Title
conventional PCI
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
PCI Suite Software
Intervention Description
PCI with PCI Suite Software
Intervention Type
Other
Intervention Name(s)
conventional PCI
Intervention Description
conventional PCI without PCI Software
Primary Outcome Measure Information:
Title
Amount of contrast medium
Description
Determination during PCI
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Major adverse cardiac and cerebrovascular events
Description
Major adverse cardiac and cerebrovascular events (MACCE) are defined as occurence of myocardial ischemia, stroke, acute stent thrombosis, major bleeding
Time Frame
Baseline, after 6 months, after 12 months
Title
Procedural success
Description
Defined by an open target vessel with a maximum of 20% residual stenosis and TIMI III flow
Time Frame
Baseline
Title
Procedure duration
Description
Determination of duration of PCI
Time Frame
Baseline
Title
area dosage product
Description
Determination during PCI
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hemodynamically relevant type A or B lesion Exclusion Criteria: hemodynamically relevant type C lesion NSTEMI/STEMI declined to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Zeus, MD
Phone
+492118118800
Email
pruefer.kardiologie@med.uni-duesseldorf.de
First Name & Middle Initial & Last Name or Official Title & Degree
Rabea Wagstaff, M.A.
Phone
+492118118914
Email
rabea.wagstaff@med.uni-duesseldorf.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Zeus, MD
Organizational Affiliation
Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology, Pulmonary Disease and Vascular Medicine
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Zeus, MD
First Name & Middle Initial & Last Name & Degree
Tobias Zeus, MD
First Name & Middle Initial & Last Name & Degree
Christian Jung, MD
First Name & Middle Initial & Last Name & Degree
Florian Bönner, MD
First Name & Middle Initial & Last Name & Degree
Laura Kleinebrecht, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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