Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)

CompletedOBSERVATIONAL
Enrollment

441

Participants

Timeline

Start Date

August 1, 2019

Primary Completion Date

March 12, 2021

Study Completion Date

March 12, 2021

Conditions
Cardiac IschemiaCoronary Artery DiseaseCoronary Stenosis
Interventions
DIAGNOSTIC_TEST

iFR

"Patients will undergo standard of care diagnostic coronary angiography using established invasive physiological criteria for iFR and FFR to aid in clinical decision making for coronary revascularization.~Angiograms will be made in at least two projections, and the treating physician will record his/her estimation of stenosis severity.~Resting iFR and Pd/Pa measures will then be made distal to the target lesion; adenosine will be administered, and the FFR measures will be made without moving the wire. An iFR pullback will then be made after hyperemia as abated. Patients will be treated or deferred from treatment based on physician decision aided by the iFR measures."

Trial Locations (40)

11576

St Francis Hospital, Roslyn

11706

South Side Hospital, Bay Shore

14203

University at Buffalo, Buffalo

19010

Bryn Mawr Hospital, Wynnewood

19096

Lankenau Medical Center, Wynnewood

27607

NC Heart & Vascular, Goldsboro

27710

Duke University Hospital, Durham

30322

Emory University Hospital, Atlanta

33021

Memorial Regional Hospital, Hollywood

33028

Memorial Hospital- West, Pembroke Pines

37203

Centennial Heart, Nashville

48236

Ascension St. John Hospital, Detroit

52803

Midwest Cardiovascular Research Foundation, Davenport

73112

Integris Heart Hospital, Oklahoma City

75246

Baylor Scott & White Research Institute, Dallas

80228

Colorado Heart and Vascular/St Anthony's, Lakewood

90822

VA Medical Center, Long Beach

99999

Wakayama Medical University, Wakayama

06510

Yale University Hospital, New Haven

03102

Catholic Medical Center, Manchester

Unknown

Unversitatklinikum, Freiburg, Freiburg im Breisgau

Gemeinschaftsklinikum, Koblenz, Koblenz

Universitatklinikum, Mannheim, Mannheim

Robert-Bosch Krankenhaus, Stuttgart, Stuttgart

University Hospital Galway, CRFG, Galway

Gifu Heart Center, Gifu

Ehime Medical University, Matsuyama

AMC Amsterdam, Amsterdam

Amphia Ziekenhuis Breda, Breda

Medische Spectrum Twente, Enschede

Medisch Centrum Leeuwarden, Leeuwarden

Sint Antonius Ziekenhuis, Nieuwegein

Radboud UMC, Nijmegen

Hospital Universitario de Léon, León

Hospital Clinico San Carlos, Madrid

Blackpool Victoria hospital, Blackpool

University of Southampton, Southampton

SS165NL

Basildon Univeristy Hospital, Basildon

BH7 7DW

Royal Bournemouth hospital, Bournemouth

W12OHS

Imperial College of London- Hammersmith Hospital, London

All Listed Sponsors
lead

Volcano Corporation

INDUSTRY

NCT03857503 - Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR) | Biotech Hunter | Biotech Hunter