Guided Physiologic Stenting for Coronary Artery Disease

(DEFINE GPS Trial)

Recruiting at 88 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

3212 Participants Needed

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.

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 data supports the effectiveness of the treatment Philips SyncVision system with Philips pressure wires for coronary artery disease?

Research shows that intracoronary stenting, which is part of the treatment, has significantly improved the safety and effectiveness of procedures for coronary artery disease by reducing vessel closure and restenosis (re-narrowing of the artery). Enhanced stent visualization systems, like the Philips SyncVision, provide better information during procedures, making them easier and potentially more effective. ^{1 2 3 4 5}

Is guided physiologic stenting for coronary artery disease safe for humans?

The safety of drug-eluting stents, which are similar to guided physiologic stenting, has been demonstrated in various high-risk patients, suggesting they are generally safe. However, the safety of these stents in some patient groups still needs more research, so caution is advised. ^{6 7 8 9 10}

How is the Guided Physiologic Stenting treatment for coronary artery disease different from other treatments?

The Guided Physiologic Stenting treatment using the Philips SyncVision system with Philips pressure wires is unique because it integrates advanced imaging and pressure measurement to guide stent placement more precisely, potentially improving outcomes by ensuring optimal stent positioning and reducing the risk of complications compared to traditional stenting methods. ^{11 12 13 14 15}

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

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

Exclusion Criteria

I have a serious heart valve problem.

I have worsening symptoms of heart failure.

I have been diagnosed with cardiogenic shock.

Timeline

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

Treatment Details

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.

Participant Groups

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

References

1. Japan pubmed.ncbi.nlm.nih.gov

Enhanced stent visualization systems during PCI: A case series and review of literature. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Coronary artery stents: evaluating new designs for contemporary percutaneous intervention. [2005]

3. United States pubmed.ncbi.nlm.nih.gov

Accurate Stent Placement in Challenging Percutaneous Coronary Interventions Using the Stent Positioning Assist System. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Stents for intracoronary placement: current status and future directions. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Coronary artery stenting: indications and cost implications. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Utility of drug-eluting stents in complex lesions and high-risk patients. [2020]

7. France pubmed.ncbi.nlm.nih.gov

Appraising the effectiveness and safety of paclitaxel-eluting stents in over 1,000 very high-risk patients: overall results of the Taxus in Real-life Usage Evaluation (TRUE) registry. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Acute and 16-month outcomes of a new stent: the first-in-man evaluation of the Medtronic S9 (integrity) stent. [2016]

9. France pubmed.ncbi.nlm.nih.gov

Randomized comparison of deliverability and in-hospital complications in implantation of BxSonic(R), Express(R), and Flexmaster(R) coronary stents. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

One-year follow-up of the Stent Restenosis (STRESS I) Study. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Orion, an improved balloon on a wire system: initial experience. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Percutaneous transluminal coronary angioplasty using a steerable guiding catheter: a new technique. [2019]

13. Hungary pubmed.ncbi.nlm.nih.gov

[Drug-eluting coronary stents]. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Integrated Stent Delivery System: A Next Generation of Stent Delivery and Drug-Eluting Stent. [2020]

15. United States pubmed.ncbi.nlm.nih.gov

Coronary stenting through 6 French guiding catheters. [2019]