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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 moreDEFINE 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious heart valve problem.I am scheduled for a heart procedure to open blocked arteries.I have worsening symptoms of heart failure.I have been diagnosed with cardiogenic shock.I need a procedure to open blocked arteries in my heart.I have irregular heartbeats that are unpredictable.I have had an iFR pullback test on my heart's arteries.I have a completely blocked artery.I have a health condition that may shorten my life to under 2 years.The size of the blood vessels around the tumor is too small.You have a large blood clot seen on an angiogram.Any blood vessel with restricted blood flow.Any non-target area with a blood vessel wider than 2.00mm.Your heart beats too fast, especially if you have uncontrolled atrial fibrillation.I have angina or a type of heart attack known as NSTEMI.Your heart's blood vessels cannot be tested using a pressure wire.Your heart's pumping ability (left ventricular ejection fraction) is less than or equal to 30%.I have no surgeries planned within a year after joining.You had silent ischemia (lack of oxygen to the heart) in the last 4 weeks.I had a major heart attack within the last 30 days.I have had a heart stent placed within the last year or plan to have one.You have a blood vessel with a blockage that needs to be treated.I have had a coronary artery bypass surgery in the past.My kidney function is very low or I am on dialysis.
Research Study Groups:
This trial has the following groups:- Group 1: physiologically-guided arm
- Group 2: angiographically-guided arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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