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

• Sponsor: Heinrich-Heine University, Duesseldorf (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03074721
• Collaborator: Philips Medical Systems (Industry)
• Enrollment: 130
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 55.3
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease	Device: PCI Suite Software; Other: conventional PCI	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: PCI Suite: Road Map Fusion Imaging in Coronary Diagnostics and Therapy
• Actual Study Start Date: Apr 24, 2017
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: PCI with PCI Suite Software	Device: PCI Suite Software; PCI with PCI Suite Software
Other: conventional PCI	Other: conventional PCI; conventional PCI without PCI Software

Outcome Measures

Primary Outcome Measures

1. Amount of contrast medium [Baseline]

   Determination during PCI

Secondary Outcome Measures

1. 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

2. Procedural success [Baseline]

   Defined by an open target vessel with a maximum of 20% residual stenosis and TIMI III flow

3. Procedure duration [Baseline]

   Determination of duration of PCI

4. area dosage product [Baseline]

   Determination during PCI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• hemodynamically relevant type A or B lesion

Exclusion Criteria:

• hemodynamically relevant type C lesion

• NSTEMI/STEMI

• declined to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Dusseldorf		Germany	40225

Sponsors and Collaborators

• Heinrich-Heine University, Duesseldorf
• Philips Medical Systems

Investigators

• Principal Investigator: Tobias Zeus, MD, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heinrich-Heine University, Duesseldorf
• ClinicalTrials.gov Identifier: NCT03074721
• Other Study ID Numbers: 16-022
• First Posted: Mar 9, 2017
• Last Update Posted: Feb 7, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Disease

Study Results

No Results Posted as of Feb 7, 2020