What side effects are associated with this type of intervention?

Common treatments for Coronary Artery Disease (CAD) similar to the iFR Co-Registration trial include percutaneous coronary intervention (PCI) with stent implantation. Known side effects of PCI can include bleeding, infection, allergic reactions to contrast dye, and complications at the catheter insertion site. Additionally, there is a risk of restenosis (re-narrowing of the artery), stent thrombosis (blood clot formation), and myocardial infarction (heart attack). Use of drug-eluting stents can also lead to delayed healing and require prolonged antiplatelet therapy, which carries its own risks such as increased bleeding.

What prior FDA approvals exist?

The FDA has approved several treatments for Coronary Artery Disease (CAD) that are similar to the iFR Co-Registration study. These include drug-eluting stents, such as everolimus-eluting stents, which release medication to prevent artery re-narrowing after PCI. Additionally, pressure wire systems like the Philips pressure guidewires used in the SyncVision co-registration system have been approved to measure fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR), aiding in the precise assessment and treatment of coronary lesions during PCI.

What other types of research exist?

Promising, novel alternatives to iFR Co-Registration for CAD patients in 2024 include: 1) FFR-CT (Fractional Flow Reserve derived from Computed Tomography), which provides non-invasive assessment of coronary artery disease; 2) Advanced OCT (Optical Coherence Tomography) imaging, offering high-resolution visualization of coronary arteries; and 3) AI-driven diagnostic platforms that integrate multimodal imaging data for enhanced decision-making in coronary interventions.

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Device

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

Must not have

Known severe aortic or mitral valve stenosis/insufficiency

Decompensated congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days, 1 year and 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have angina or a type of heart attack known as NSTEMI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart valve problem.

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I have worsening symptoms of heart failure.

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I have been diagnosed with cardiogenic shock.

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I have irregular heartbeats that are unpredictable.

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I have had an iFR pullback test on my heart's arteries.

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I have a completely blocked artery.

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I have a health condition that may shorten my life to under 2 years.

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I have had a heart stent placed within the last year or plan to have one.

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I have had a coronary artery bypass surgery in the past.

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My kidney function is very low or I am on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days, 1 year and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days, 1 year and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 1 year and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Angina-related Quality of Life

Cost effectiveness

Resource utilization

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Coronary Artery Disease (CAD) include lifestyle modifications, medications, and revascularization procedures. iFR Co-Registration, a technique used during Percutaneous Coronary Intervention (PCI), measures pressure differences across coronary lesions without inducing hyperemia, allowing for precise stent placement. This method, along with other treatments like statins, antiplatelets, and beta-blockers, aims to reduce symptoms, prevent complications, and improve blood flow to the heart, ultimately enhancing patient outcomes.

Safety and efficacy of coronary laser ablation as an adjunctive therapy in percutaneous coronary intervention: a single-centre experience.Efficacy of primary treatment with immunoglobulin plus ciclosporin for prevention of coronary artery abnormalities in patients with Kawasaki disease predicted to be at increased risk of non-response to intravenous immunoglobulin (KAICA): a randomised controlled, open-label, blinded-endpoints, phase 3 trial.Does intravascular ultrasound provide clinical benefits for percutaneous coronary intervention with bare-metal stent implantation? A meta-analysis of randomized controlled trials.