PRESSUREwire Study
- Conditions
- Acute Coronary SyndromeCoronary Artery Disease
- Registration Number
- NCT02935088
- Lead Sponsor
- Abbott Medical Devices
- 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,
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2217
- 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
- Patient has extremely tortuous or calcified coronary arteries
- Patient with a patent coronary artery bypass graft to the target vessel
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (71)
St.-Johannes-Hospital
🇩🇪Dortmund, Germany
Providence Everett Medical Center
🇺🇸Everett, Washington, United States
Krankenhaus Lainz
🇦🇹Vienna, Austria
Lisie Hospital
🇮🇳Kochi, India
London Health Sciences Centre
🇨🇦London, Canada
Centro Cardiologico Monzino
🇮🇹Milano, Italy
Alexandra General Hospital
🇬🇷Athens, Greece
Medizinische Einrichtungen der Universität Düsseldorf
🇩🇪Dusseldorf, Germany
Universitätsklinikum Aachen
🇩🇪Aachen, Germany
University Hospital of Ioannina
🇬🇷Ioannina, Greece
Policlinico Universitario A. Gemelli
🇮🇹Roma, Italy
Ospedale Maggiore-Bellaria
🇮🇹Bologna, Italy
Aswan Cardiac Center
🇪🇬Aswan, Egypt
Kliniken Villingen-Schwenningen
🇩🇪Villingen-Schwenningen, Germany
Apollo Hospital
🇮🇳Chennai, India
The Madras Medical Mission
🇮🇳Chennai, India
Al Dorrah Heart Care Hospital
🇪🇬Cairo, Egypt
Haga Ziekenhuis Locatie Leyenburg
🇳🇱Den Haag, Netherlands
Onze Lieve Vrouw Gasthuis
🇳🇱Amsterdam, Netherlands
Orlando Health
🇺🇸Orlando, Florida, United States
Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States
Kliniken der Friedrich-Alexander-Universitat
🇩🇪Erlangen, Germany
Christian Medical College & Hospital
🇮🇳Vellore, India
Azienda Ospedaliera Monaldi
🇮🇹Napoli, Italy
Policlinico di Modena
🇮🇹Modena, Italy
Ospedale di Trento - P.O.Santa Chiara
🇮🇹Trento, Italy
Gifu Heart Center
🇯🇵Gifu-shi, Japan
Tokyo Medical University Hachioji Medical Center
🇯🇵Hachioji, Japan
Kansai Rosai Hospital
🇯🇵Hyogo, Japan
Yokosuka Kyosai Hospital
🇯🇵Kanagawa, Japan
Kanazawa Cardiovascular Hospital
🇯🇵Kanazawa, Japan
Tenyoukai Central Hospital
🇯🇵Kagoshima-shi, Japan
Gunma Prefectural Cardiovascular Center
🇯🇵Maebashi-shi, Japan
Nishinomiya Watanabe Cardiovascular Center
🇯🇵Nishinomiya-shi, Japan
Sapporo Cardiovascular Clinic
🇯🇵Sapporo-shi, 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-shi, Japan
VU Amsterdam
🇳🇱Amsterdam, Netherlands
Amphia Hospital
🇳🇱Breda, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Santa Maria Hospital
🇵🇹Lisboa, Portugal
King Abdullah Medical City
🇸🇦Mecca, Saudi Arabia
Hospital de Basurto
🇪🇸Bilbao, Spain
Hospital Asistencial Universitario de Burgos
🇪🇸Burgos, Spain
Complejo Hospitalario de Jaen
🇪🇸Jaen, Spain
Hospital Universitario Son Espases
🇪🇸Palma de Mallorca, Spain
Hospital Universitario Donostia
🇪🇸San Sebastian, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Complejo Hospital Nuestra Señora de la Candelaria
🇪🇸Santa Cruz De Tenerife, Spain
Golden Jubilee National Hospital
🇬🇧Clydebank, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
St. Bartholomew's Hospital
🇬🇧London, United Kingdom
Allgemeines Krankenhaus Linz
🇦🇹Linz, Austria
Tartu University Hospital
🇪🇪Tartu, Estonia
Medanta - The Medicity Hospital
🇮🇳Gurgaon, India
Hospital Garcia de Orta, EPE
🇵🇹Almada, Portugal
Centro Hospitalar Vila Nova Gaia
🇵🇹Vila Nova de Gaia, Portugal
North Estonia Medical Centre
🇪🇪Tallinn, Estonia
Postgraduate Institute of Medical Education & Research
🇮🇳Chandigarh, India
Caritas Hospital
🇮🇳Kottayam, India
Fortis Escorts Hospital, Jaipur
🇮🇳Jaipur, India
Sree Chitra Tirunal Institute for Medical Sciences and tech.
🇮🇳Trivandrum, India
Hospital do Divino EspÃrito Santo
🇵🇹Ponta Delgada, Portugal
Sunshine Hospitals
🇮🇳Secunderabad, India
Ananthapuri Hospitals and Research Institute
🇮🇳Thiruvananthapuram, India
King Khalid University Hospital
🇸🇦Riyadh, Saudi Arabia
Kettering General Hospital
🇬🇧Kettering, United Kingdom
Atlanta VA Medical Center
🇺🇸Decatur, Georgia, United States
Hopital Sacre Coeur
🇨🇦Montreal, Canada