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

Recruiting in Palo Alto (17 mi)

+88 other locations

Overseen byAllen Jeremias, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Philips Clinical & Medical Affairs Global

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial compares two methods for guiding a heart procedure called PCI. It targets patients who need this procedure. One method uses X-ray images, and the other uses pressure measurements to help doctors see where to work during the procedure.

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for a heart procedure to open blocked arteries.

I need a procedure to open blocked arteries in my heart.

Subject is willing to comply with all scheduled visits and tests and has provided informed written consent

+1 more

Exclusion Criteria

I have a serious heart valve problem.

I have worsening symptoms of heart failure.

I have been diagnosed with cardiogenic shock.

+22 more

Participant Groups

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.

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