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Guided Physiologic Stenting for Coronary Artery Disease (DEFINE GPS Trial)

N/A
Waitlist Available
Led By Allen Jeremias, MD MSC FACC FSCAI
Research Sponsored by Philips Clinical & Medical Affairs Global
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing cardiac catheterization with planned PCI or possible ad hoc PCI
Following angiography, PCI is indicated in at least one coronary artery based on specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

DEFINE GPS Trial Summary

This trial is testing whether a new angiography method is better than the current one for guiding coronary stents.

Who is the study for?
This trial is for adults with stable or unstable angina, or NSTEMI who are undergoing cardiac catheterization and may need PCI. They should be willing to follow the study plan and give informed consent. Exclusions include severe heart failure, recent major heart procedures, pregnancy, other ongoing clinical studies, substance abuse issues, certain arrhythmias, and planned surgeries.Check my eligibility
What is being tested?
The study compares two methods of guiding PCI in coronary artery disease: standard angiography versus intravascular pressure sensor guidance using Philips SyncVision system. It's a multi-center trial that randomly assigns participants to either method and can adjust its size based on interim results.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks of PCI include bleeding at the catheter insertion site, blood vessel damage during the procedure, allergic reactions to contrast dye used in angiography, irregular heartbeats (arrhythmias), and rarely heart attack.

DEFINE GPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a heart procedure to open blocked arteries.
Select...
I need a procedure to open blocked arteries in my heart.
Select...
I have angina or a type of heart attack known as NSTEMI.

DEFINE GPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Major Adverse Cardiac Events (MACE; composite of cardiac death, MI, or ischemia-driven revascularization) or hospitalization for progressive or unstable angina at 2 years
Secondary outcome measures
All MI, target vessel MI, non-target vessel MI, procedural MI, non-procedural MI
All-cause, cardiac and non-cardiac mortality
Angina-related Quality of Life
+6 more

DEFINE GPS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: physiologically-guided armExperimental Treatment1 Intervention
Physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy
Group II: angiographically-guided armActive Control1 Intervention
Standard of care angiographically-guided PCI for determining the PCI strategy

Find a Location

Who is running the clinical trial?

Philips Clinical & Medical Affairs GlobalLead Sponsor
47 Previous Clinical Trials
12,638 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
371 Patients Enrolled for Coronary Artery Disease
Allen Jeremias, MD MSC FACC FSCAIPrincipal InvestigatorSaint Francis Hospital
Gregg W Stone, MDStudy ChairThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai
15 Previous Clinical Trials
18,061 Total Patients Enrolled
10 Trials studying Coronary Artery Disease
13,348 Patients Enrolled for Coronary Artery Disease

Media Library

Philips SyncVision system with Philips pressure wires (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04451044 — N/A
Coronary Artery Disease Research Study Groups: physiologically-guided arm, angiographically-guided arm
Coronary Artery Disease Clinical Trial 2023: Philips SyncVision system with Philips pressure wires Highlights & Side Effects. Trial Name: NCT04451044 — N/A
Philips SyncVision system with Philips pressure wires (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04451044 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any remaining capacity in this clinical trial for participants?

"This research initiative, which was initially advertised on June 17th 2021, is not currently seeking participants. However, there are an abundance of other medical trials that are actively recruiting; 750 to be exact."

Answered by AI

Are there a multitude of healthcare facilities conducting this experiment?

"Clinical trial participants are being recruited from St. Michael's Hospital in Toronto, William Osler Health-Brampton Civic Hospital in Brampton, and Gates Vascular Institute located in Buffalo with several other sites comprising the total of 34 recruitment centres."

Answered by AI
~1415 spots leftby Jun 2026