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

NCT04451044 | Enrolling By Invitation FDA Device

• 1 other identifier: 190103
• Study Type: interventional
• Target: 3,212
• Locations: 17 countries
• Sites: 83

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.

Conditions

Coronary Artery Disease; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (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

  2 years

Secondary Outcomes (9)

• 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

Study Arms (2)

physiologically-guided arm

EXPERIMENTAL

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

Device: Philips SyncVision system with Philips pressure wires

angiographically-guided arm

ACTIVE COMPARATOR

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

Procedure: standard of care angiographically-guided PCI

Interventions

Philips SyncVision system with Philips pressure wires DEVICE

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

physiologically-guided arm

standard of care angiographically-guided PCI PROCEDURE

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

angiographically-guided arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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
• \. 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..
• Subject is willing to comply with all scheduled visits and tests and has provided informed written consent

You may not qualify if:

• \. 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)
• \. Prior CABG anytime
• \. 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
• \. Presence of unstable ventricular arrhythmias
• \. Heart rate \> 110, including uncontrolled atrial fibrillation (AF)
• \. Decompensated congestive heart failure (NYHA Class IV or Killip Class III or IV)
• \. 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)
• \. 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (84)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

Pima Heart & Vascular

Tucson, Arizona, 85716, United States

Location

Central Arkansas Veterans Healthcare System (CAVHS)

Little Rock, Arkansas, 72205, United States

Location

Glendale Adventist

Glendale, California, 91206, United States

Location

Colorado Heart and Vascular

Lakewood, Colorado, 80228, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Memorial Healthcare

Hollywood, Florida, 33201, United States

Location

Tampa Cardiovascular Innovations and Research

Tampa, Florida, 33607, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Straub Medical Center

Honolulu, Hawaii, 96813, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

Community Healthcare System

Munster, Indiana, 46321, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Mass General

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Metro Cardiology Consultants

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Health Services

Edina, Minnesota, 55435, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Gates Vascular Institute

Buffalo, New York, 14203, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607, United States

Location

Summa Health System

Akron, Ohio, 44304, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Jefferson Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

North Central Heart

Sioux Falls, South Dakota, 57108, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Ascension Saint Thomas

Nashville, Tennessee, 37205, United States

Location

Baylor Scott & White, The Heart Hospital Plano

Plano, Texas, 75093, United States

Location

Sentara Health

Norfolk, Virginia, 23502, United States

Location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

Gundersen Health

La Crosse, Wisconsin, 54601, United States

Location

Gosford Hospital

Gosford, New South Wales, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, Australia

Location

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Location

Prince of Wales Hospital

Sydney, New South Wales, Australia

Location

Lake Macquarie Private Hospital

Gateshead, Australia

Location

The Alfred Hospital

Melbourne, Australia

Location

Akademisches Lehrkrankenhaus Feldkirch

Feldkirch, Austria

Location

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

William Osler Health-Brampton Civic Hospital

Brampton, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Canada

Location

St. Michael's Hospital

Toronto, Canada

Location

Aarhus University Hospital

Aarhus, Denmark

Location

CHU Lille, Institut Coeur Poumon

Lille, France

Location

CHU Nimes Caremeau

Nîmes, France

Location

Vivantes Klinikum im Friedrichshain

Berlin, 10249, Germany

Location

Erlangen University Hospital

Erlangen, Germany

Location

University Hospital Essen

Essen, Germany

Location

Universitsklinik Freiburg

Freiburg im Breisgau, Germany

Location

Hillel Yaffe Medical Center

Hadera, Israel

Location

Shamir Medical Center

Tel Aviv, Israel

Location

Careggi University Hospital

Florence, Italy

Location

Hospital General Querétaro

Querétaro, Mexico

Location

Albert Schweitzer Ziekenhuis / Hartcentum Dordrecht- Gorinchem

Dordrecht, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

St Antonius Hospital Nieuwegein

Nieuwegein, Netherlands

Location

Radboud University Med Ctr

Nijmegen, Netherlands

Location

Medical University of Warsaw

Warsaw, Poland

Location

Hospital Prof. Doutour Fernando Foneseca

Amadora, Portugal

Location

Sejong General Hospital

Bucheon-si, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario de Leon

León, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Universitario Marqués de Valdecillas

Santander, Spain

Location

Skane University Hospital

Lund, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Geneva University Hospital

Geneva, Switzerland

Location

University Hospital Southampton

Southampton, Hampshire, S016 6YD, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Allen Jeremias, MD MSC FACC FSCAI

  Saint Francis Hospital

  PRINCIPAL INVESTIGATOR

• Gregg W Stone, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 30, 2020
• Study Start: June 17, 2021
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); FR (2); AU (6); US (40); DE (4); CA (5); KR (3); ME (1); DK (1); NL (5); IL (2); SE (2); GB (4); IT (1); CH (1); PL (1); PT (1)