Coronary Artery DiseaseNCT02935088
PRESSUREwire Study
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by Abbott Medical Devices at 71 sites in 15 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- Fractional Flow Reserve
- Type of treatment
- Medical device
- How many people
- 2,217 participants
- Where
- 71 sitesin 15 countries
- Study dates
- 12 Oct 2016to 22 Mar 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients where FFR has been performed or is planned to be performed for further evaluation of PCI procedures, as per physician clinical practice.
Who may be able to join
- 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
Who cannot join
- Patient has extremely tortuous or calcified coronary arteries
- Patient with a patent coronary artery bypass graft to the target vessel
Trial locations and contacts
71 sites in 15 countries.
71 sites in 15 countries
Japan13 sites
Gifu Heart Center
Gifu
Tokyo Medical University Hachioji Medical Center
Hachiōji
Kansai Rosai Hospital
Hyōgo
Tenyoukai Central Hospital
Kagoshima
Yokosuka Kyosai Hospital
Kanagawa
Kanazawa Cardiovascular Hospital
Kanazawa
Gunma Prefectural Cardiovascular Center
Maebashi
Nishinomiya Watanabe Cardiovascular Center
Nishinomiya-shi
Sapporo Cardiovascular Clinic
Sapporo
Tohoku University Hospital
Sendai
Higashi Takarazuka Satoh Hospital
Takarazuka
Tsuchiura Kyodo General Hospital
Tsuchiura-shi
Yokohama City University Medical Center
Yokohama
India11 sites
Postgraduate Institute of Medical Education & Research
Chandigarh
Apollo Hospital
Chennai
The Madras Medical Mission
Chennai
Medanta - The Medicity Hospital
Gūrgaon
Fortis Escorts Hospital, Jaipur
Jaipur
Lisie Hospital
Kochi
Caritas Hospital
Kottayam
Sunshine Hospitals
Secunderabad
Ananthapuri Hospitals and Research Institute
Thiruvananthapuram
Sree Chitra Tirunal Institute for Medical Sciences and tech.
Trivandrum
Christian Medical College & Hospital
Vellore
Spain7 sites
Hospital de Basurto
Bilbao, 48013
Hospital Asistencial Universitario de Burgos
Burgos, 09006
Hospital Universitario Donostia
Donostia / San Sebastian
Complejo Hospitalario de Jaen
Jaén, 23007
Hospital Universitario Son Espases
Palma de Mallorca
Complejo Hospital Nuestra Señora de la Candelaria
Santa Cruz de Tenerife
Hospital Universitario Marqués de Valdecilla
Santander
Italy6 sites
Ospedale Maggiore-Bellaria
Bologna
Centro Cardiologico Monzino
Milan, 20138
Policlinico di Modena
Modena
Azienda Ospedaliera Monaldi
Naples
Policlinico Universitario A. Gemelli
Roma
Ospedale di Trento - P.O.Santa Chiara
Trento
Germany5 sites
Universitätsklinikum Aachen
Aachen
St.-Johannes-Hospital
Dortmund
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf
Kliniken der Friedrich-Alexander-Universitat
Erlangen, 91054
Kliniken Villingen-Schwenningen
Villingen-Schwenningen
Netherlands5 sites
VU Amsterdam
Amsterdam, 1081HV
Onze Lieve Vrouw Gasthuis
Amsterdam, 1091 AC
Amphia Hospital
Breda
Catharina Ziekenhuis
Eindhoven
Haga Ziekenhuis Locatie Leyenburg
The Hague, 2545AA
United States4 sites
Atlanta VA Medical Center
Decatur, Georgia, 30033
Providence Everett Medical Center
Everett, Washington, 98206
Heart Center Research, LLC
Huntsville, Alabama, 35801
Orlando Health
Orlando, Florida, 32806
Portugal4 sites
Hospital Garcia de Orta, EPE
Almada
Santa Maria Hospital
Lisbon
Hospital do Divino Espírito Santo
Ponta Delgada
Centro Hospitalar Vila Nova Gaia
Vila Nova de Gaia
United Kingdom4 sites
Golden Jubilee National Hospital
Clydebank
Kettering General Hospital
Kettering
Royal Free Hospital
London
St. Bartholomew's Hospital
London
Austria2 sites
Allgemeines Krankenhaus Linz
Linz, 4020
Krankenhaus Lainz
Vienna
Estonia2 sites
North Estonia Medical Centre
Tallinn
Tartu University Hospital
Tartu
Greece2 sites
Alexandra General Hospital
Athens
University Hospital of Ioannina
Ioannina
Saudi Arabia2 sites
King Abdullah Medical City
Mecca
King Khalid University Hospital
Riyadh
About this study
Official title: Practical Evaluation of Fractional Flow Reserve (FFR) and Its Associated Alternate Indices During Routine Clinical Procedures
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.
Read the detailed description
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
- Coronary Artery Disease, Acute Coronary Syndrome
- Being tested
- Fractional Flow Reserve
- Keywords
- FFR, Percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Flow ReserveDevice
Also called PressureWire
Measurement of physiologic parameters
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start12 Oct 2016
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colin Berry, MD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935088
- Sponsor's protocol ID
- SJM-CIP-10136
- Status last verified
- Jan 2020
- First submitted
- 13 Oct 2016
- Last updated
- 7 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32170905
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Evaluation of Fractional Flow Reserve (FFR) and Its Associated Alternate Indices During Routine Clinical Procedures
- ClinicalTrials.gov ID
- NCT02935088
- Acronym / sponsor ID
- SJM-CIP-10136
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Keywords
- FFR, Percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,217 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Posted 7 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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,
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients where FFR has been performed or is planned to be performed for further evaluation of PCI procedures, as per physician clinical practice.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patient has extremely tortuous or calcified coronary arteries
- Patient with a patent coronary artery bypass graft to the target vessel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional Flow ReserveAlso: PressureWireMeasurement of physiologic parameters | Device | – |
Primary outcome
Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices
Time frame: 12 months
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32170905Schampaert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Berry, MD principal investigator
University of Glasgow
71 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by Abbott Medical Devices at 71 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in Japan, India, Spain, Italy, Germany and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02935088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.