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Coronary Artery DiseaseDEFINE GPSNCT04451044

Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting

A study testing Philips SyncVision system with Philips pressure wires in people with Coronary Artery Disease and Ischemic Heart Disease, run by Philips Clinical & Medical Affairs Global at 84 sites in 18 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Philips SyncVision system with Philips pressure wires
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,212 participants
Where
84 sitesin 18 countries
Study dates
17 Jun 2021to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Adult men and women (local age of consent) who present with stable or unstable angina, or NSTEMI.
  • 2. Undergoing cardiac catheterization with planned PCI or possible ad hoc PCI
  • 3. Following angiography, PCI is indicated in at least one coronary artery* on the basis of one or more of the following:
  • Presenting with NSTE-ACS (unstable angina with ECG changes or cardiac enzyme-positive NSTEMI) with an identified culprit lesion with DS ≥50%;
  • One or more angiographic stenoses present with ≥80% stenosis severity by visual estimation;
  • One or more angiographic stenoses present with ≥50% to <80% stenosis severity by visual estimation and an abnormal non-invasive stress test in the distribution of the lesion(s) within the past 60 days;
  • One or more angiographic stenoses are present with ≥50% to <80% stenosis severity by visual estimation and a spot iFR measure ≤0.89 or FFR≤0.80 for borderline iFR..
  • 4 Subject is willing to comply with all scheduled visits and tests and has provided informed written consent

Who cannot join

  • 1. STEMI within 30 days
  • 2. PCI within the prior 12 months, or any PCI planned after the study procedure (other than planned staged procedures of randomized vessels which are allowed)
  • 3. Prior CABG anytime
  • 4. Silent ischemia only (i.e. no cardiac symptoms related to coronary artery disease) within the prior 4 weeks
  • 5. Documented prior iFR pullback performed in any coronary artery including during the qualifying diagnostic angiogram
  • 6. Any vessel with in-stent restenosis (ISR) requiring treatment
Show all 25Show fewer
  • 7. Cardiogenic shock defined as systolic blood pressure <90 mmHg for >20 minutes not responding to fluid resuscitation, or need for inotropic, pressor, or device-based hemodynamic support
  • 8. Presence of unstable ventricular arrhythmias
  • 9. Heart rate > 110, including uncontrolled atrial fibrillation (AF)
  • 10. Decompensated congestive heart failure (NYHA Class IV or Killip Class III or IV)
  • 11. Chronic total occlusion (CTO) of a target vessel (exception: a CTO may be present in a non-target vessel if it is supplying non-viable myocardium and there is no intent to open the CTO during the index or later procedure)
  • 12. 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 passed to the distal third of the three major epicardial coronary arteries
  • 13. Any angiographic giant thrombus (i.e., thrombus length > 3x RVD at lesion)
  • 14. Any target vessel with < TIMI III flow
  • 15. Any target lesion with a reference vessel diameter (RVD) less than 2.25mm except for within the side branch of a bifurcation lesion
  • 16. Any non-target lesion with a reference vessel diameter (RVD) greater than 2.00mm that contains an ≥80% stenosis and is not intended for treatment with PCI (other than a CTO supplying non-viable myocardium - see exclusion #11)
  • 17. Known severe aortic or mitral valve stenosis/insufficiency
  • 18. Known non-cardiovascular comorbidity resulting in lifespan <24 months
  • 19. Known left ventricular ejection fraction ≤30%
  • 20. Estimated creatinine clearance (MDRD formula) <30 mL/min/1.73m2 or on dialysis
  • 21. Any cardiac or non-cardiac surgical procedure planned within 12 months after enrollment, or any procedure planned within 6 months after enrollment that would necessitate discontinuation of dual antiplatelet therapy
  • 22. Known pregnancy or planning to become pregnant (women of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
  • 23. Participating in another investigational drug or device study that has not reached its primary endpoint
  • 24. Any condition such as dementia or substance abuse that may impair the patient's ability to comply with all study procedures, including medication compliance and follow-up visits
  • 25. Patient is a member of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also include university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Trial locations and contacts

84 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

84 sites in 18 countries

United States40 sites

  • Summa Health System

    Akron, Ohio, 44304

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

  • Mass General

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Gates Vascular Institute

    Buffalo, New York, 14203

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Metro Cardiology Consultants

    Coon Rapids, Minnesota, 55433

  • Fairview Health Services

    Edina, Minnesota, 55435

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Glendale Adventist

    Glendale, California, 91206

  • Memorial Healthcare

    Hollywood, Florida, 33201

  • Straub Medical Center

    Honolulu, Hawaii, 96813

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Gundersen Health

    La Crosse, Wisconsin, 54601

  • Northwell Health

    Lake Success, New York, 11042

  • Colorado Heart and Vascular

    Lakewood, Colorado, 80228

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Central Arkansas Veterans Healthcare System (CAVHS)

    Little Rock, Arkansas, 72205

  • Community Healthcare System

    Munster, Indiana, 46321

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Ascension Saint Thomas

    Nashville, Tennessee, 37205

  • Yale University

    New Haven, Connecticut, 06520

  • Columbia University Medical Center

    New York, New York, 10032

  • Sentara Health

    Norfolk, Virginia, 23502

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Jefferson Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • Baylor Scott & White, The Heart Hospital Plano

    Plano, Texas, 75093

  • NC Heart and Vascular Research, LLC

    Raleigh, North Carolina, 27607

  • Carilion Clinic

    Roanoke, Virginia, 24014

  • St. Francis Hospital

    Roslyn, New York, 11576

  • North Central Heart

    Sioux Falls, South Dakota, 57108

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Tampa Cardiovascular Innovations and Research

    Tampa, Florida, 33607

  • Pima Heart & Vascular

    Tucson, Arizona, 85716

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Australia6 sites

  • Lake Macquarie Private Hospital

    Gateshead

  • Gosford Hospital

    Gosford, New South Wales

  • Liverpool Hospital

    Liverpool, New South Wales

  • The Alfred Hospital

    Melbourne

  • Royal North Shore Hospital

    Saint Leonards, New South Wales

  • Prince of Wales Hospital

    Sydney, New South Wales

Other trials in Australia

Canada5 sites

  • William Osler Health-Brampton Civic Hospital

    Brampton

  • Montreal Heart Institute

    Montreal, Quebec

  • Hopital du Sacre-Coeur de Montreal

    Montreal

  • Royal Columbian Hospital

    New Westminster, British Columbia

  • St. Michael's Hospital

    Toronto

Other trials in Canada

Netherlands5 sites

  • Albert Schweitzer Ziekenhuis / Hartcentum Dordrecht- Gorinchem

    Dordrecht

  • Medisch Spectrum Twente

    Enschede

  • Medisch Centrum Leeuwarden

    Leeuwarden

  • St Antonius Hospital Nieuwegein

    Nieuwegein

  • Radboud University Med Ctr

    Nijmegen

Other trials in Netherlands

Germany4 sites

  • Vivantes Klinikum im Friedrichshain

    Berlin, 10249

  • Erlangen University Hospital

    Erlangen

  • University Hospital Essen

    Essen

  • Universitsklinik Freiburg

    Freiburg im Breisgau

Other trials in Germany

Spain4 sites

  • Hospital Universitario Reina Sofía

    Córdoba

  • Hospital Universitario de Leon

    León

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Universitario Marqués de Valdecillas

    Santander

Other trials in Spain

United Kingdom4 sites

  • Royal Bournemouth Hospital

    Bournemouth

  • University Hospital of Wales

    Cardiff, Wales

  • Imperial College Healthcare NHS Trust

    London

  • University Hospital Southampton

    Southampton, Hampshire, S016 6YD

Other trials in United Kingdom

South Korea3 sites

  • Sejong General Hospital

    Bucheon-si

  • Keimyung University Dongsan Medical Center

    Daegu

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

France2 sites

  • CHU Lille, Institut Coeur Poumon

    Lille

  • CHU Nimes Caremeau

    Nîmes

Other trials in France

Israel2 sites

  • Hillel Yaffe Medical Center

    Hadera

  • Shamir Medical Center

    Tel Aviv

Other trials in Israel

Sweden2 sites

  • Skane University Hospital

    Lund

  • Örebro University Hospital

    Örebro

Other trials in Sweden

Austria1 site

  • Akademisches Lehrkrankenhaus Feldkirch

    Feldkirch

Other trials in Austria

Denmark1 site

  • Aarhus University Hospital

    Aarhus

Other trials in Denmark

Italy1 site

  • Careggi University Hospital

    Florence

Other trials in Italy

Mexico1 site

  • Hospital General Querétaro

    Querétaro

Other trials in Mexico

Poland1 site

  • Medical University of Warsaw

    Warsaw

Other trials in Poland

Portugal1 site

  • Hospital Prof. Doutour Fernando Foneseca

    Amadora

Other trials in Portugal

Switzerland1 site

  • Geneva University Hospital

    Geneva

Other trials in Switzerland

About this study

Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation.

Read the detailed description

DEFINE GPS Substudy: Characterization of Intermediate Lesions (ChIL) will enroll approximately 350 patients at up to 20 sites. This multi-center, prospective, registry will enroll patients consented to be randomized into the DEFINE GPS study but ultimately screen fail. Baseline patient medical and demographic data will be collected along with angiographic and functional data from vessels with intermediate disease deferred from revascularization and will be used to establish a body of imaging data that can be used to validate new image-based physiology applications.

Being tested
Philips SyncVision system with Philips pressure wires, standard of care angiographically-guided PCI
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Philips SyncVision system with Philips pressure wiresDevice

    Intent to use physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy

  • standard of care angiographically-guided PCIProcedure or surgery

    Intent to use PCI standard of care angiographically-guided PCI for determining the PCI strategy

Study groups in NCT04451044
Study groupRoleWhat they receive
physiologically-guided armExperimentalPhysiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy
Receives: Device: Philips SyncVision system with Philips pressure wires
angiographically-guided armActive comparatorStandard of care angiographically-guided PCI for determining the PCI strategy
Receives: Procedure: standard of care angiographically-guided PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiac Events (MACE; composite of cardiac death, target vessel MI (TVMI), or ischemia-driven revascularization) or hospitalization for progressive or unstable angina at 2 years

    Measured: 2 years

Secondary outcomes (9)

  1. Major Adverse Cardiac Events (MACE; composite of cardiac death, target vessel MI (TVMI), or ischemia-driven revascularization) or hospitalization for progressive or unstable angina

    Measured: 30 days, 1 year

  2. All-cause, cardiac and non-cardiac mortality

    Measured: 30 days, 1 year and 2 years

  3. All MI, target vessel MI, non-target vessel MI, procedural MI, non-procedural MI

    Measured: 30 days, 1 year and 2 years

  4. Ischemia-driven revascularization, including all revascularization, TVR, TLR, non-TLR TVR, and non-TVR

    Measured: 30 days, 1 year and 2 years

  5. Hospitalization for progressive or unstable ischemia

    Measured: 30 days, 1 year and 2 years

  6. Stent thrombosis (definite, probable and definite/probable)

    Measured: 30 days, 1 year and 2 years

  7. Angina-related Quality of Life

    Change from baseline in the Seattle Angina Questionnaire (SAQ-7) summary score

    Measured: 30 days, 1 year and 2 years

  8. Resource utilization

    The [US-based] cost of all health care resources associated with the index procedure and pre-specified event costs throughout the two-year follow up period

    Measured: 30 days, 1 year and 2 years

  9. Cost effectiveness

    Cost per quality-adjusted life years gained

    Measured: 30 days, 1 year and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study start17 Jun 2021
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
3,212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04451044
Sponsor's protocol ID
190103
Acronym
DEFINE GPS
Status last verified
Jan 2025
First submitted
23 Jun 2020
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Philips SyncVision system with Philips pressure wires in people with Coronary Artery Disease and Ischemic Heart Disease, run by Philips Clinical & Medical Affairs Global at 84 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Australia, Canada, Netherlands, Germany and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiac Events (MACE; composite of cardiac death, target vessel MI (TVMI), or ischemia-driven revascularization) or hospitalization for progressive or unstable angina at 2 years (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04451044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.

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