Guided Physiologic Stenting for Coronary Artery Disease

(DEFINE GPS Trial)

Enrolling by invitation at 96 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Philips Clinical & Medical Affairs Global

Disqualifiers: STEMI, Prior CABG, Cardiogenic shock, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods used during a heart procedure called PCI, which opens blocked coronary arteries. One group will receive the standard method guided by imaging, while the other will use the Philips SyncVision system with Philips pressure wires to measure blood flow and guide the procedure. The trial seeks individuals with angina (chest pain) or a recent mild heart attack who are scheduled for a heart procedure. Participants will help researchers determine which method more effectively treats coronary artery disease. As an unphased trial, this study allows participants to contribute to advancing medical knowledge and improving future heart procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Philips SyncVision system with Philips pressure wires is safe for coronary artery disease treatment?

Research has shown that the Philips SyncVision system with Philips pressure wires is generally well-tolerated by patients treated for coronary artery disease. Studies have found that this system can enhance procedural efficiency by improving accuracy and reducing treatment time, suggesting it is a reliable and safe option for many patients.

Initial findings indicate that the pressure wires in the system help pinpoint problem areas in the arteries, leading to more precise treatment. Although specific side effects are not detailed in the sources, the system is designed to enhance safety by ensuring treatments are as targeted as possible.

The trial is in a phase that does not require extensive early safety testing, which usually indicates the treatment is considered safe enough for broader testing. This type of trial typically relies on previous safety data, demonstrating confidence in the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial of physiologically-guided stenting for coronary artery disease because it offers a more tailored approach to determining the PCI strategy. Unlike traditional methods that rely on angiographic guidance, which primarily uses X-ray images to assess blockages, the Philips SyncVision system utilizes pressure wires to provide detailed physiological data. This allows for a more precise understanding of blood flow and potentially improves the accuracy of stent placement, leading to better patient outcomes. By moving beyond the visual assessment of arteries, this technique could enhance treatment effectiveness and reduce the risk of complications.

What evidence suggests that this trial's treatments could be effective for coronary artery disease?

Research has shown that the Philips SyncVision system with Philips pressure wires, which participants in this trial may receive, can aid in treating coronary artery disease. This technology enables doctors to see blockages more clearly and select the best treatment. Studies have found that the SyncVision system enhances treatment precision and reduces procedure times. As a result, patients might experience better outcomes with fewer complications. Early evidence suggests this system could significantly improve the success of heart procedures. Meanwhile, another group in this trial will receive standard of care angiographically-guided PCI, the current standard method for determining the PCI strategy. ^{1 5 6 7 8}

Who Is on the Research Team?

Allen Jeremias, MD

Principal Investigator

Saint Francis Hospital

Gregg W Stone, MD

Principal Investigator

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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

Exclusion Criteria

I have a serious heart valve problem.

I have worsening symptoms of heart failure.

I have been diagnosed with cardiogenic shock.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PCI guided by either angiography or iFR Co-Registration using Philips pressure guidewires and the SyncVision system

4-6 weeks

Follow-up

Participants are monitored for safety, effectiveness, and resource utilization after treatment

2 years

Regular visits at 30 days, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Philips SyncVision system with Philips pressure wires
• standard of care angiographically-guided PCI

Trial Overview 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.

How Is the Trial Designed?

Group I: physiologically-guided arm Experimental Treatment 1 Intervention

Physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy

Group II: angiographically-guided arm Active Control 1 Intervention

Standard of care angiographically-guided PCI for determining the PCI strategy

Who Is Running the Clinical Trial?

Philips Clinical & Medical Affairs Global

Lead Sponsor

Trials

61

Recruited

17,600+

Roy Jakobs

Philips Clinical & Medical Affairs Global

Chief Executive Officer since 2022

MBA from Erasmus University Rotterdam

Carla Goulart Peron

Philips Clinical & Medical Affairs Global

Chief Medical Officer since 2023

MD from an unspecified institution

Citations

1. usa.philips.com usa.philips.com/healthcare/image-guided-therapy/coronary-suite

Coronary suite Improve coronary artery disease care with Philips' solutions for better diagnosis, treatment and outcomes in cath labs.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04451044

Study Details | NCT04451044 | Distal Evaluation of ... Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips ...

3. usa.philips.com usa.philips.com/healthcare/product/HCIGTDSYNC/syncvision-precision-guidance-system

SyncVision precision guidance system The SyncVision precision guidance system streamlines lesion assessment, simplifies vessel sizing, and enables precise therapy delivery in conjunction with ...

4. philips.rs philips.rs/healthcare/medical-specialties/cardiology/cad-clinical-efficiency/treatment

Coronary artery disease - Treatment Effective, efficient treatment in coronary artery disease. Access clinical insights and increase confidence in treatment while reducing procedure time.

5. withpower.com withpower.com/trial/phase-myocardial-ischemia-5-2021-ebf19

Guided Physiologic Stenting for Coronary Artery Disease ... What data supports the effectiveness of the treatment Philips SyncVision system with Philips pressure wires for coronary artery disease? Research shows that ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04451044

Study Details | NCT04451044 | Distal Evaluation of ... Coronary anatomy not amenable to pressure wire manipulation due to extreme tortuosity or complexity such that it is unlikely that a pressure wire could be ...

7. philips.com philips.com/a-w/about/news/archive/standard/news/articles/2025/define-gps-trial-marks-major-milestone-in-interventional-cardiology.html

DEFINE GPS trial marks major milestone in interventional ... IFR co-registration adds a pressure wire that measures where pressure drops in the coronary arteries—those areas may be causing symptoms or ...

8. philips.com.tr philips.com.tr/healthcare/medical-specialties/cardiology/cad-clinical-efficiency/treatment

Coronary artery disease - Treatment Effective, efficient treatment in coronary artery disease. Access clinical insights and increase confidence in treatment while reducing procedure time.