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

NCT ID: NCT04451044

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 3212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2028-06-30

Brief 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.

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.

Conditions

Coronary Artery Disease; Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

physiologically-guided arm

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

Group Type: EXPERIMENTAL

Philips SyncVision system with Philips pressure wires

Intervention Type: DEVICE

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

angiographically-guided arm

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

Group Type: ACTIVE_COMPARATOR

standard of care angiographically-guided PCI

Intervention Type: PROCEDURE

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

Interventions

Philips SyncVision system with Philips pressure wires

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

Intervention Type: DEVICE

standard of care angiographically-guided PCI

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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:

1. Presenting with NSTE-ACS (unstable angina with ECG changes or cardiac enzyme-positive NSTEMI) with an identified culprit lesion with DS ≥50%;

2. One or more angiographic stenoses present with ≥80% stenosis severity by visual estimation;

3. 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;

4. 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

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allen Jeremias, MD MSC FACC FSCAI

Role: PRINCIPAL_INVESTIGATOR

Saint Francis Hospital

Gregg W Stone, MD

Role: STUDY_CHAIR

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

Locations

University of Alabama Birmingham

Birmingham, Alabama, United States

Pima Heart & Vascular

Tucson, Arizona, United States

Central Arkansas Veterans Healthcare System (CAVHS)

Little Rock, Arkansas, United States

Glendale Adventist

Glendale, California, United States

Colorado Heart and Vascular

Lakewood, Colorado, United States

Yale University

New Haven, Connecticut, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Memorial Healthcare

Hollywood, Florida, United States

Tampa Cardiovascular Innovations and Research

Tampa, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Straub Medical Center

Honolulu, Hawaii, United States

Carle Foundation Hospital

Urbana, Illinois, United States

Community Healthcare System

Munster, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Mass General

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Metro Cardiology Consultants

Coon Rapids, Minnesota, United States

Fairview Health Services

Edina, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Gates Vascular Institute

Buffalo, New York, United States

Northwell Health

Lake Success, New York, United States

Columbia University Medical Center

New York, New York, United States

St. Francis Hospital

Roslyn, New York, United States

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, United States

Summa Health System

Akron, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Jefferson Einstein Medical Center

Philadelphia, Pennsylvania, United States

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

North Central Heart

Sioux Falls, South Dakota, United States

Centennial Medical Center

Nashville, Tennessee, United States

Ascension Saint Thomas

Nashville, Tennessee, United States

Baylor Scott & White, The Heart Hospital Plano

Plano, Texas, United States

Sentara Health

Norfolk, Virginia, United States

Carilion Clinic

Roanoke, Virginia, United States

Gundersen Health

La Crosse, Wisconsin, United States

Gosford Hospital

Gosford, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Prince of Wales Hospital

Sydney, New South Wales, Australia

Lake Macquarie Private Hospital

Gateshead, , Australia

The Alfred Hospital

Melbourne, , Australia

Akademisches Lehrkrankenhaus Feldkirch

Feldkirch, , Austria

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

William Osler Health-Brampton Civic Hospital

Brampton, , Canada

Hopital du Sacre-Coeur de Montreal

Montreal, , Canada

St. Michael's Hospital

Toronto, , Canada

Aarhus University Hospital

Aarhus, , Denmark

CHU Lille, Institut Coeur Poumon

Lille, , France

CHU Nimes Caremeau

Nîmes, , France

Vivantes Klinikum im Friedrichshain

Berlin, , Germany

Erlangen University Hospital

Erlangen, , Germany

University Hospital Essen

Essen, , Germany

Universitsklinik Freiburg

Freiburg im Breisgau, , Germany

Hillel Yaffe Medical Center

Hadera, , Israel

Shamir Medical Center

Tel Aviv, , Israel

Careggi University Hospital

Florence, , Italy

Hospital General Querétaro

Querétaro, , Mexico

Albert Schweitzer Ziekenhuis / Hartcentum Dordrecht- Gorinchem

Dordrecht, , Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

St Antonius Hospital Nieuwegein

Nieuwegein, , Netherlands

Radboud University Med Ctr

Nijmegen, , Netherlands

Medical University of Warsaw

Warsaw, , Poland

Hospital Prof. Doutour Fernando Foneseca

Amadora, , Portugal

Sejong General Hospital

Bucheon-si, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Hospital Universitario Reina Sofía

Córdoba, , Spain

Hospital Universitario de Leon

León, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Universitario Marqués de Valdecillas

Santander, , Spain

Skane University Hospital

Lund, , Sweden

Örebro University Hospital

Örebro, , Sweden

Geneva University Hospital

Geneva, , Switzerland

University Hospital Southampton

Southampton, Hampshire, United Kingdom

University Hospital of Wales

Cardiff, Wales, United Kingdom

Royal Bournemouth Hospital

Bournemouth, , United Kingdom

Imperial College Healthcare NHS Trust

London, , United Kingdom

Countries

United States; Australia; Austria; Canada; Denmark; France; Germany; Israel; Italy; Mexico; Netherlands; Poland; Portugal; South Korea; Spain; Sweden; Switzerland; United Kingdom

Other Identifiers

190103

Identifier Type: -

Identifier Source: org_study_id