Philips SyncVision system with Philips pressure wiresstandard of care angiographically-guided PCI
Philips SyncVision system with Philips pressure wires: Intent to use physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy
standard of care angiographically-guided PCI: Intent to use PCI standard of care angiographically-guided PCI for determining the PCI strategy
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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
Trial sites (84)
Facility
City
Region
Status
University of Alabama Birmingham
Birmingham
Alabama
Pima Heart & Vascular
Tucson
Arizona
Central Arkansas Veterans Healthcare System (CAVHS)
Little Rock
Arkansas
Glendale Adventist
Glendale
California
Colorado Heart and Vascular
Lakewood
Colorado
Yale University
New Haven
Connecticut
MedStar Washington Hospital Center
Washington D.C.
District of Columbia
Memorial Healthcare
Hollywood
Florida
Tampa Cardiovascular Innovations and Research
Tampa
Florida
Emory University Hospital
Atlanta
Georgia
Northeast Georgia Medical Center
Gainesville
Georgia
Straub Medical Center
Honolulu
Hawaii
Carle Foundation Hospital
Urbana
Illinois
Community Healthcare System
Munster
Indiana
University of Kansas Medical Center
Kansas City
Kansas
Mass General
Boston
Massachusetts
Brigham and Women's Hospital
Boston
Massachusetts
Metro Cardiology Consultants
Coon Rapids
Minnesota
Fairview Health Services
Edina
Minnesota
Washington University School of Medicine
St Louis
Missouri
University of Nebraska Medical Center
Omaha
Nebraska
Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
Gates Vascular Institute
Buffalo
New York
Northwell Health
Lake Success
New York
Columbia University Medical Center
New York
New York
St. Francis Hospital
Roslyn
New York
NC Heart and Vascular Research, LLC
Raleigh
North Carolina
Summa Health System
Akron
Ohio
Cleveland Clinic
Cleveland
Ohio
Bryn Mawr Hospital
Bryn Mawr
Pennsylvania
Jefferson Einstein Medical Center
Philadelphia
Pennsylvania
UPMC Presbyterian
Pittsburgh
Pennsylvania
Lankenau Medical Center
Wynnewood
Pennsylvania
North Central Heart
Sioux Falls
South Dakota
Centennial Medical Center
Nashville
Tennessee
Ascension Saint Thomas
Nashville
Tennessee
Baylor Scott & White, The Heart Hospital Plano
Plano
Texas
Sentara Health
Norfolk
Virginia
Carilion Clinic
Roanoke
Virginia
Gundersen Health
La Crosse
Wisconsin
+ 44 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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