PRESSUREwire Study

NCT ID: NCT02935088

Last Updated: 2020-02-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2217 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-12

Study Completion Date

2019-03-22

Brief Summary

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The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.

Detailed Description

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The purpose of this study is to understand routine use of FFR and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.

The study will also collect data on the routine use of coronary physiologic measurements such as adenosine-induced hyperemia FFR, FFR by contrast-induced hyperemia,

Conditions

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Coronary Artery Disease Acute Coronary Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Fractional Flow Reserve

Measurement of physiologic parameters

Intervention Type DEVICE

Other Intervention Names

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PressureWire

Eligibility Criteria

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Inclusion Criteria

* Patient is presenting with STEMI, NSTEMI, unstable angina, or stable coronary artery disease
* Patient is planned to have FFR performed or underwent a cardiac catheterization where FFR was performed for further PCI (Percutaneous Cardiac Intervention) consideration
* Patient signs and dates written informed consent
* Patient is eighteen years of age or older at the time of consent

Exclusion Criteria

* Patient has extremely tortuous or calcified coronary arteries
* Patient with a patent coronary artery bypass graft to the target vessel
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Colin Berry, MD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

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Heart Center Research, LLC

Huntsville, Alabama, United States

Site Status

Orlando Health

Orlando, Florida, United States

Site Status

Atlanta VA Medical Center

Decatur, Georgia, United States

Site Status

Providence Everett Medical Center

Everett, Washington, United States

Site Status

Allgemeines Krankenhaus Linz

Linz, , Austria

Site Status

Krankenhaus Lainz

Vienna, , Austria

Site Status

London Health Sciences Centre

London, , Canada

Site Status

Hopital Sacre Coeur

Montreal, , Canada

Site Status

Aswan Cardiac Center

Aswān, , Egypt

Site Status

Al Dorrah Heart Care Hospital

Cairo, , Egypt

Site Status

North Estonia Medical Centre

Tallinn, , Estonia

Site Status

Tartu University Hospital

Tartu, , Estonia

Site Status

Universitätsklinikum Aachen

Aachen, , Germany

Site Status

St.-Johannes-Hospital

Dortmund, , Germany

Site Status

Medizinische Einrichtungen der Universität Düsseldorf

Düsseldorf, , Germany

Site Status

Kliniken der Friedrich-Alexander-Universitat

Erlangen, , Germany

Site Status

Kliniken Villingen-Schwenningen

Villingen-Schwenningen, , Germany

Site Status

Alexandra General Hospital

Athens, , Greece

Site Status

University Hospital of Ioannina

Ioannina, , Greece

Site Status

Postgraduate Institute of Medical Education & Research

Chandigarh, , India

Site Status

Apollo Hospital

Chennai, , India

Site Status

The Madras Medical Mission

Chennai, , India

Site Status

Medanta - The Medicity Hospital

Gurgaon, , India

Site Status

Fortis Escorts Hospital, Jaipur

Jaipur, , India

Site Status

Lisie Hospital

Kochi, , India

Site Status

Caritas Hospital

Kottayam, , India

Site Status

Sunshine Hospitals

Secunderabad, , India

Site Status

Ananthapuri Hospitals and Research Institute

Thiruvananthapuram, , India

Site Status

Sree Chitra Tirunal Institute for Medical Sciences and tech.

Trivandrum, , India

Site Status

Christian Medical College & Hospital

Vellore, , India

Site Status

Ospedale Maggiore-Bellaria

Bologna, , Italy

Site Status

Centro Cardiologico Monzino

Milan, , Italy

Site Status

Policlinico di Modena

Modena, , Italy

Site Status

Azienda Ospedaliera Monaldi

Napoli, , Italy

Site Status

Policlinico Universitario A. Gemelli

Roma, , Italy

Site Status

Ospedale di Trento - P.O.Santa Chiara

Trento, , Italy

Site Status

Gifu Heart Center

Gifu, , Japan

Site Status

Tokyo Medical University Hachioji Medical Center

Hachiōji, , Japan

Site Status

Kansai Rosai Hospital

Hyōgo, , Japan

Site Status

Tenyoukai Central Hospital

Kagoshima, , Japan

Site Status

Yokosuka Kyosai Hospital

Kanagawa, , Japan

Site Status

Kanazawa Cardiovascular Hospital

Kanazawa, , Japan

Site Status

Gunma Prefectural Cardiovascular Center

Maebashi, , Japan

Site Status

Nishinomiya Watanabe Cardiovascular Center

Nishinomiya-shi, , Japan

Site Status

Sapporo Cardiovascular Clinic

Sapporo, , Japan

Site Status

Tohoku University Hospital

Sendai, , Japan

Site Status

Higashi Takarazuka Satoh Hospital

Takarazuka, , Japan

Site Status

Tsuchiura Kyodo General Hospital

Tsuchiura-shi, , Japan

Site Status

Yokohama City University Medical Center

Yokohama, , Japan

Site Status

VU Amsterdam

Amsterdam, , Netherlands

Site Status

Onze Lieve Vrouw Gasthuis

Amsterdam, , Netherlands

Site Status

Amphia Hospital

Breda, , Netherlands

Site Status

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

Haga Ziekenhuis Locatie Leyenburg

The Hague, , Netherlands

Site Status

Hospital Garcia de Orta, EPE

Almada, , Portugal

Site Status

Santa Maria Hospital

Lisbon, , Portugal

Site Status

Hospital do Divino Espírito Santo

Ponta Delgada, , Portugal

Site Status

Centro Hospitalar Vila Nova Gaia

Vila Nova de Gaia, , Portugal

Site Status

King Abdullah Medical City

Mecca, , Saudi Arabia

Site Status

King Khalid University Hospital

Riyadh, , Saudi Arabia

Site Status

Hospital de Basurto

Bilbao, , Spain

Site Status

Hospital Asistencial Universitario de Burgos

Burgos, , Spain

Site Status

Hospital Universitario Donostia

Donostia / San Sebastian, , Spain

Site Status

Complejo Hospitalario de Jaen

Jaén, , Spain

Site Status

Hospital Universitario Son Espases

Palma de Mallorca, , Spain

Site Status

Complejo Hospital Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, , Spain

Site Status

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Site Status

Golden Jubilee National Hospital

Clydebank, , United Kingdom

Site Status

Kettering General Hospital

Kettering, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

St. Bartholomew's Hospital

London, , United Kingdom

Site Status

Countries

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United States Austria Canada Egypt Estonia Germany Greece India Italy Japan Netherlands Portugal Saudi Arabia Spain United Kingdom

References

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Schampaert E, Kumar G, Achenbach S, Galli S, Tanaka N, Teraphongphom T, Ginn G, Zhang Z, Somi S, Amoroso G, Brueren G, Krasnow J, Knaapen P, Berry C; PRESSUREwire Investigators. A global registry of fractional flow reserve (FFR)-guided management during routine care: Study design, baseline characteristics and outcomes of invasive management. Catheter Cardiovasc Interv. 2020 Oct 1;96(4):E423-E431. doi: 10.1002/ccd.28827. Epub 2020 Mar 14.

Reference Type DERIVED
PMID: 32170905 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SJM-CIP-10136

Identifier Type: -

Identifier Source: org_study_id

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