PRESSUREwire Study
Practical Evaluation of Fractional Flow Reserve (FFR) and Its Associated Alternate Indices During Routine Clinical Procedures
1 other identifier
observational
2,217
14 countries
69
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Typical duration for all trials
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2016
CompletedFirst Submitted
Initial submission to the registry
October 13, 2016
CompletedFirst Posted
Study publicly available on registry
October 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2019
CompletedResults Posted
Study results publicly available
February 7, 2020
CompletedFebruary 7, 2020
January 1, 2020
2.4 years
October 13, 2016
October 2, 2019
January 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices
Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization. Fisher Exact test will be performed to evaluate the association between 12-month MACE event and binary FFR variables respectively using the following FFR; Low FFR group (FFR ≤ 0.8) and high FFR group (FFR \> 0.8).
12 months
Other Outcomes (5)
Correlation of Resting Indices With FFR Values
at time of procedure
Number of Subjects Who Had a Change in Treatment Plan When FFR is Used Compared to the Initial Decision Based on Angiography Alone
at time of procedure
Number of Subjects With 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up Subjects in Whom the Use of FFR Did Not Lead to a Change in Treatment Decision vs Subjects in Whom the Use of FFR Led to a Change in Treatment Decision
12 months
- +2 more other outcomes
Interventions
Eligibility Criteria
Patients where FFR has been performed or is planned to be performed for further evaluation of PCI procedures, as per physician clinical practice.
You may qualify if:
- 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
You may not qualify if:
- Patient has extremely tortuous or calcified coronary arteries
- Patient with a patent coronary artery bypass graft to the target vessel
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Orlando Health
Orlando, Florida, 32806, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Providence Everett Medical Center
Everett, Washington, 98206, United States
Allgemeines Krankenhaus Linz
Linz, 4020, Austria
Krankenhaus Lainz
Vienna, Austria
London Health Sciences Centre
London, Canada
Hopital Sacre Coeur
Montreal, Canada
Aswan Cardiac Center
Aswān, Egypt
Al Dorrah Heart Care Hospital
Cairo, Egypt
North Estonia Medical Centre
Tallinn, Estonia
Tartu University Hospital
Tartu, Estonia
Universitätsklinikum Aachen
Aachen, Germany
St.-Johannes-Hospital
Dortmund, Germany
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf, Germany
Kliniken der Friedrich-Alexander-Universitat
Erlangen, 91054, Germany
Kliniken Villingen-Schwenningen
Villingen-Schwenningen, Germany
Alexandra General Hospital
Athens, Greece
University Hospital of Ioannina
Ioannina, Greece
Postgraduate Institute of Medical Education & Research
Chandigarh, India
Apollo Hospital
Chennai, India
The Madras Medical Mission
Chennai, India
Medanta - The Medicity Hospital
Gūrgaon, India
Fortis Escorts Hospital, Jaipur
Jaipur, India
Lisie Hospital
Kochi, India
Caritas Hospital
Kottayam, India
Sunshine Hospitals
Secunderabad, India
Ananthapuri Hospitals and Research Institute
Thiruvananthapuram, India
Sree Chitra Tirunal Institute for Medical Sciences and tech.
Trivandrum, India
Christian Medical College & Hospital
Vellore, India
Ospedale Maggiore-Bellaria
Bologna, Italy
Centro Cardiologico Monzino
Milan, 20138, Italy
Policlinico di Modena
Modena, Italy
Azienda Ospedaliera Monaldi
Napoli, Italy
Policlinico Universitario A. Gemelli
Roma, Italy
Ospedale di Trento - P.O.Santa Chiara
Trento, Italy
Gifu Heart Center
Gifu, Japan
Tokyo Medical University Hachioji Medical Center
Hachiōji, Japan
Kansai Rosai Hospital
Hyōgo, Japan
Tenyoukai Central Hospital
Kagoshima, Japan
Yokosuka Kyosai Hospital
Kanagawa, Japan
Kanazawa Cardiovascular Hospital
Kanazawa, Japan
Gunma Prefectural Cardiovascular Center
Maebashi, Japan
Nishinomiya Watanabe Cardiovascular Center
Nishinomiya-shi, Japan
Sapporo Cardiovascular Clinic
Sapporo, Japan
Tohoku University Hospital
Sendai, Japan
Higashi Takarazuka Satoh Hospital
Takarazuka, Japan
Tsuchiura Kyodo General Hospital
Tsuchiura-shi, Japan
Yokohama City University Medical Center
Yokohama, Japan
VU Amsterdam
Amsterdam, 1081HV, Netherlands
Onze Lieve Vrouw Gasthuis
Amsterdam, 1091 AC, Netherlands
Amphia Hospital
Breda, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Haga Ziekenhuis Locatie Leyenburg
The Hague, 2545AA, Netherlands
Hospital Garcia de Orta, EPE
Almada, Portugal
Santa Maria Hospital
Lisbon, Portugal
Hospital do Divino Espírito Santo
Ponta Delgada, Portugal
Centro Hospitalar Vila Nova Gaia
Vila Nova de Gaia, Portugal
King Abdullah Medical City
Mecca, Saudi Arabia
King Khalid University Hospital
Riyadh, Saudi Arabia
Hospital de Basurto
Bilbao, 48013, Spain
Hospital Asistencial Universitario de Burgos
Burgos, 09006, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
Complejo Hospitalario de Jaen
Jaén, 23007, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Spain
Complejo Hospital Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Golden Jubilee National Hospital
Clydebank, United Kingdom
Kettering General Hospital
Kettering, United Kingdom
Royal Free Hospital
London, United Kingdom
St. Bartholomew's Hospital
London, United Kingdom
Related Publications (1)
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.
PMID: 32170905DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tarn Teraphongphom, Sr. Clinical Scientist
- Organization
- Abbott Vascular
Study Officials
- PRINCIPAL INVESTIGATOR
Colin Berry, MD
University of Glasgow
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2016
First Posted
October 17, 2016
Study Start
October 12, 2016
Primary Completion
March 22, 2019
Study Completion
March 22, 2019
Last Updated
February 7, 2020
Results First Posted
February 7, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share