Clinical trial NCT02935088: PRESSUREwire Study
Official title: Practical Evaluation of Fractional Flow Reserve (FFR) and Its Associated Alternate Indices During Routine Clinical Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Keywords: FFR
Percutaneous coronary intervention
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-10-17
Enrollment: 2217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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,

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Correlation of Resting Indices With FFR Values
timeFrame: at time of procedure
measure: Number of Subjects Who Had a Change in Treatment Plan When FFR is Used Compared to the Initial Decision Based on Angiography Alone
timeFrame: at time of procedure
measure: 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
timeFrame: 12 months
measure: Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR)
timeFrame: 12 months
measure: Correlation of Other PressureWire-derived Index, Contrast FFR With FFR Values
timeFrame: at time of procedure
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Everett
country: United States
facility: Providence Everett Medical Center
state: Washington
city: Linz
country: Austria
facility: Allgemeines Krankenhaus Linz
city: Vienna
country: Austria
facility: Krankenhaus Lainz
city: London
country: Canada
facility: London Health Sciences Centre
city: Montreal
country: Canada
facility: Hopital Sacre Coeur
city: Aswan
country: Egypt
facility: Aswan Cardiac Center
city: Cairo
country: Egypt
facility: Al Dorrah Heart Care Hospital
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital
city: Dusseldorf
country: Germany
facility: Medizinische Einrichtungen der Universität Düsseldorf
city: Erlangen
country: Germany
facility: Kliniken der Friedrich-Alexander-Universitat
city: Villingen-Schwenningen
country: Germany
facility: Kliniken Villingen-Schwenningen
city: Athens
country: Greece
facility: Alexandra General Hospital
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research
city: Chennai
country: India
facility: Apollo Hospital
city: Chennai
country: India
facility: The Madras Medical Mission
city: Gurgaon
country: India
facility: Medanta - The Medicity Hospital
city: Jaipur
country: India
facility: Fortis Escorts Hospital, Jaipur
city: Kochi
country: India
facility: Lisie Hospital
city: Kottayam
country: India
facility: Caritas Hospital
city: Secunderabad
country: India
facility: Sunshine Hospitals
city: Thiruvananthapuram
country: India
facility: Ananthapuri Hospitals and Research Institute
city: Trivandrum
country: India
facility: Sree Chitra Tirunal Institute for Medical Sciences and tech.
city: Vellore
country: India
facility: Christian Medical College & Hospital
city: Bologna
country: Italy
facility: Ospedale Maggiore-Bellaria
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Modena
country: Italy
facility: Policlinico di Modena
city: Napoli
country: Italy
facility: Azienda Ospedaliera Monaldi
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli
city: Trento
country: Italy
facility: Ospedale di Trento - P.O.Santa Chiara
city: Gifu-shi
country: Japan
facility: Gifu Heart Center
city: Hachioji
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
city: Hyogo
country: Japan
facility: Kansai Rosai Hospital
city: Kagoshima-shi
country: Japan
facility: Tenyoukai Central Hospital
city: Kanagawa
country: Japan
facility: Yokosuka Kyosai Hospital
city: Kanazawa
country: Japan
facility: Kanazawa Cardiovascular Hospital
city: Maebashi-shi
country: Japan
facility: Gunma Prefectural Cardiovascular Center
city: Nishinomiya-shi
country: Japan
facility: Nishinomiya Watanabe Cardiovascular Center
city: Sapporo-shi
country: Japan
facility: Sapporo Cardiovascular Clinic
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Takarazuka
country: Japan
facility: Higashi Takarazuka Satoh Hospital
city: Tsuchiura-shi
country: Japan
facility: Tsuchiura Kyodo General Hospital
city: Yokohama-shi
country: Japan
facility: Yokohama City University Medical Center
city: Amsterdam
country: Netherlands
facility: VU Amsterdam
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouw Gasthuis
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis Locatie Leyenburg
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, EPE
city: Lisboa
country: Portugal
facility: Santa Maria Hospital
city: Ponta Delgada
country: Portugal
facility: Hospital do Divino Espírito Santo
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova Gaia
city: Mecca
country: Saudi Arabia
facility: King Abdullah Medical City
city: Riyadh
country: Saudi Arabia
facility: King Khalid University Hospital
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Burgos
country: Spain
facility: Hospital Asistencial Universitario de Burgos
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: San Sebastian
country: Spain
facility: Hospital Universitario Donostia
city: Santa Cruz De Tenerife
country: Spain
facility: Complejo Hospital Nuestra Señora de la Candelaria
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Kettering
country: United Kingdom
facility: Kettering General Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
Study officials:
affiliation: University of Glasgow
name: Colin Berry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.