Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting
- Conditions
- Coronary Artery DiseaseIschemic Heart Disease
- Interventions
- Device: Philips SyncVision system with Philips pressure wiresProcedure: standard of care angiographically-guided PCI
- Registration Number
- NCT04451044
- Lead Sponsor
- Philips Clinical & Medical Affairs Global
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 3212
-
- Adult men and women (local age of consent) who present with stable or unstable angina, or NSTEMI.
-
- Undergoing cardiac catheterization with planned PCI or possible ad hoc PCI
-
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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%;
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One or more angiographic stenoses present with ≥80% stenosis severity by visual estimation;
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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;
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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
-
- STEMI within 30 days
-
- 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)
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- Prior CABG anytime
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- Silent ischemia only (i.e. no cardiac symptoms related to coronary artery disease) within the prior 4 weeks
-
- Documented prior iFR pullback performed in any coronary artery including during the qualifying diagnostic angiogram
-
- Any vessel with in-stent restenosis (ISR) requiring treatment
-
- 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
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- Presence of unstable ventricular arrhythmias
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- Heart rate > 110, including uncontrolled atrial fibrillation (AF)
-
- Decompensated congestive heart failure (NYHA Class IV or Killip Class III or IV)
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- 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)
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- 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
-
- Any angiographic giant thrombus (i.e., thrombus length > 3x RVD at lesion)
-
- Any target vessel with < TIMI III flow
-
- Any target lesion with a reference vessel diameter (RVD) less than 2.25mm except for within the side branch of a bifurcation lesion
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- 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)
-
- Known severe aortic or mitral valve stenosis/insufficiency
-
- Known non-cardiovascular comorbidity resulting in lifespan <24 months
-
- Known left ventricular ejection fraction ≤30%
-
- Estimated creatinine clearance (MDRD formula) <30 mL/min/1.73m2 or on dialysis
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- 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
-
- Known pregnancy or planning to become pregnant (women of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
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- Participating in another investigational drug or device study that has not reached its primary endpoint
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- 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
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- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description physiologically-guided arm Philips SyncVision system with Philips pressure wires Physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy angiographically-guided arm standard of care angiographically-guided PCI Standard of care angiographically-guided PCI for determining the PCI strategy
- Primary Outcome Measures
Name Time Method 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 2 years
- Secondary Outcome Measures
Name Time Method Stent thrombosis (definite, probable and definite/probable) 30 days, 1 year and 2 years Major Adverse Cardiac Events (MACE; composite of cardiac death, target vessel MI (TVMI), or ischemia-driven revascularization) or hospitalization for progressive or unstable angina 30 days, 1 year All-cause, cardiac and non-cardiac mortality 30 days, 1 year and 2 years All MI, target vessel MI, non-target vessel MI, procedural MI, non-procedural MI 30 days, 1 year and 2 years Ischemia-driven revascularization, including all revascularization, TVR, TLR, non-TLR TVR, and non-TVR 30 days, 1 year and 2 years Hospitalization for progressive or unstable ischemia 30 days, 1 year and 2 years Angina-related Quality of Life 30 days, 1 year and 2 years Change from baseline in the Seattle Angina Questionnaire (SAQ-7) summary score
Resource utilization 30 days, 1 year and 2 years 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
Cost effectiveness 30 days, 1 year and 2 years Cost per quality-adjusted life years gained
Trial Locations
- Locations (84)
Sentara Health
🇺🇸Norfolk, Virginia, United States
The Alfred Hospital
🇦🇺Melbourne, Australia
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, 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
🇺🇸Saint 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
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Columbia University Medical Center
🇺🇸New York, 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
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
Gundersen Health
🇺🇸La Crosse, Wisconsin, United States
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
Gosford Hospital
🇦🇺Gosford, New South Wales, Australia
Akademisches Lehrkrankenhaus Feldkirch
🇦🇹Feldkirch, Austria
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
Montreal Heart Institute
🇨🇦Montréal, Quebec, Canada
Aarhus University Hospital
🇩🇰Aarhus, Denmark
William Osler Health-Brampton Civic Hospital
🇨🇦Brampton, Canada
Hopital du Sacre-Coeur de Montreal
🇨🇦Montréal, Canada
St. Michael's Hospital
🇨🇦Toronto, Canada
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, Germany
Hillel Yaffe Medical Center
🇮🇱Hadera, Israel
Shamir Medical Center
🇮🇱Tel Aviv, Israel
Careggi University Hospital
🇮🇹Florence, Italy
Sejong General Hospital
🇰🇷Bucheon, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
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
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