Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation
- Conditions
- Coronary Artery Disease
- Interventions
- Device: iFRDevice: FFR
- Registration Number
- NCT02053038
- Lead Sponsor
- Imperial College London
- Brief Summary
Narrowing of coronary arteries interferes with blood flow and can cause chest pain. But patients may have more than one narrowing and studies have shown that not all narrowings need to be treated. To identify the narrowings that need treating cardiologists sometimes quantify the extent of the narrowing by measuring fractional flow reserve (FFR, the ratio of the pressure in the aorta to the pressure downstream of the narrowing).This technique requires the administration of drugs that add cost and time to the procedure and in some countries are simply unavailable. As a result despite the clear health and healthcare costs benefits of FFR its use is limited to less than 5% of procedure. We have developed a new technique called the instantaneous wave-free ratio (iFR) that does not require the administration of drugs for its accurate assessment. It has been approved for use in this indication. This study aims to compare clinical outcomes of patients whose treatment has been guided by iFR to those whose treatment has been guided by FFR. If iFR is found to provide the same clinical outcomes as FFR its adoption will permit the clear benefits of this approach of identifying the coronary narrowings that really need treatment to be applicable to a much larger patient population and further improve healthcare costs.
- Detailed Description
Design:
Patients with one or more coronary stenoses, in which the physiological severity from coronary angiography is in question, will be randomised 1:1 to use of the instantaneous wave free ratio (iFR) or fractional flow reserve (FFR) to guide the treatment strategy for percutaneous coronary intervention (PCI).
Aims:
To assess whether the iFR is non-inferior to FFR when used to guide treatment of coronary stenosis with PCI.
Outcome measures:
The primary endpoint will be major adverse cardiac event rate in the iFR and FFR groups at 30 days, 1, 2, and 5 years.
Population:
This will be an international multi-centre study of 2500 patients. From population estimates, 35% of the total study population will present with stable angina and 65% will have acute coronary syndrome.
Eligibility:
Patients will be eligible when the physiological severity of a stenosis within a vessel is in question. In the cases of stable angina this will be confined to the target vessel, or with acute coronary syndrome assessment this will be made in the non-culprit vessel.
Duration:
Anticipated recruitment is 12 months. Follow-up will be performed at 30 days, 1, 2 and 5 years.
Results:
Primary outcome results will be reported in Spring 2017.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2500
- Age > 18 years of age
- Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
- Eligible for coronary angiography and/or percutaneous coronary intervention
- Coronary artery disease with at least 1 or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which the physiological severity of the lesion is in question (typically 40-70% diameter stenosis).
- Stable angina or acute coronary syndrome (non-culprit vessels only and outside of primary intervention during acute STEMI)
Exclusion criteria:
- Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
- Significant left main stenosis (>50% narrowing)
- Tandem stenoses separated by more than 10 mm that require separate pressure guide wire interrogation or percutaneous coronary intervention (PCI) (not to be interrogated or treated as a single stenosis)
- Total coronary occlusions (CTOs). NOTE: Patients with CTOs can be included if i) treatment of the CTO is completed first, ii) the CTO PCI is successful, iii) the CTO PCI is successful and iii) the physiological lesion is in another vessel
- Restenotic lesions
- Hemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg), balloon pump
- Significant contraindication to adenosine administration (e.g. heart block, severe asthma)
- Contraindications to PCI (percutaneous coronary intervention) or drug-eluting stent (DES) implantation
- Heavily calcified or tortuous vessels
- Significant hepatic or lung disease (chronic pulmonary obstructive disease), and/or malignant disease with unfavourable prognosis that may influence survival within the next 5 years
- Pregnancy
- STEMI (ST elevation myocardial infarction) within 48 hours of procedure
- Severe valvular heart disease
- ACS patients in whom more than one target vessel is present
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description iFR iFR Treatment guided by iFR FFR FFR Treatment guided by FFR
- Primary Outcome Measures
Name Time Method Major Adverse Cardiac Events 30 days, 1, 2 and 5 years Composite of death, myocardial infarction, unplanned revascularisation
- Secondary Outcome Measures
Name Time Method Cost associated to iFR or FFR measurement 30 days, 1, 2 and 5 years Cost associated to iFR or FFR
Death (all cause) 30 days, 1, 2 and 5 years Death (cardiovascular) 30 days, 1, 2 and 5 years Myocardial Infarction 30 days, 1, 2 and 5 years Cost savings of removing secondary investigations 30 days, 1, 2 and 5 years 7) Cost savings of removing secondary investigations, by assessing/treating non-culprit acute coronary syndrome (ACS) at the time of index presentation.
Repeat revascularisation 30 days, 1, 2 and 5 years Quality of life assessed by EQ-5D-5L and Seattle Angina Questionnaire 30 days, 1, 2 and 5 years
Trial Locations
- Locations (50)
Eduardo Alegria
🇪🇸Madrid, Spain
Sergio Baptista
🇵🇹Amadora, Portugal
Bon-Kwon Koo
🇰🇷Seoul, Korea, Republic of
Nob Tanaka
🇯🇵Tokyo, Japan
Andrejs Erglis
🇱🇻Riga, Latvia
Hiroaki Takashima
🇯🇵Aichi, Japan
Joon-Hyung Doh
🇰🇷Daehwa, Korea, Republic of
Hiroyoshi Yokoi
🇯🇵Fukuoka, Japan
Habib Samady
🇺🇸Atlanta, Georgia, United States
Pedro Canas Silva
🇵🇹Lisbon, Portugal
Robert Gerber
🇬🇧St Leonards, United Kingdom
Yuetsu Kikuta
🇯🇵Fukuyama, Japan
Allen Jeremias
🇺🇸Stony Brook, New York, United States
Arnold Seto
🇺🇸Long Beach, California, United States
John Altman
🇺🇸Lakewood, Colorado, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Manesh Patel
🇺🇸Durham, North Carolina, United States
Sam Lehman
🇦🇺Adelaide, Australia
Ravinay Bhindi
🇦🇺Sydney, Australia
Darren Walters
🇦🇺Brisbane, Australia
James Sapontis
🇦🇺Melbourne, Australia
Christian Vrints
🇧🇪Antwerp, Belgium
Luc Janssens
🇧🇪Bonheiden, Belgium
Ahmed Khashaba
🇪🇬Cairo, Egypt
Florian Krackhardt
🇩🇪Berlin, Germany
Mika Laine
🇫🇮Helsinki, Finland
Tobias Haerle
🇩🇪Oldenburg, Germany
Olaf Going
🇩🇪Berlin, Germany
Waldemar Bojara
🇩🇪Koblenz, Germany
Ciro Indolfi
🇮🇹Catanzaro, Italy
Flavio Ribichini
🇮🇹Verona, Italy
Giampaolo Nicolli
🇮🇹Rome, Italy
Hitosh Matsuo
🇯🇵Gifu, Japan
Chang-Wook Nam
🇰🇷Daegu, Korea, Republic of
Jan Piek
🇳🇱Amsterdam, Netherlands
Niels Van Royen
🇳🇱Amsterdam, Netherlands
Eun-Seok Shin
🇰🇷Ulsan, Korea, Republic of
Martijn Meuwissen
🇳🇱Breda, Netherlands
Hugo Vinhas
🇵🇹Almada, Portugal
Ali Alghamadi
🇸🇦Riyadh, Saudi Arabia
Farrel Hellig
🇿🇦Johannesburg, South Africa
Salvatore Brugaletta
🇪🇸Barcelona, Spain
Clinico San Carlos
🇪🇸Madrid, Spain
Murat Sezer
🇹🇷Istanbul, Turkey
Kare Tang
🇬🇧Basildon, United Kingdom
Suneel Talwar
🇬🇧Bournemouth, United Kingdom
Imperial College London
🇬🇧London, United Kingdom
Andrew Sharp
🇬🇧Exeter, United Kingdom
Ranil De Silva
🇬🇧London, United Kingdom
Rajesh Kharbanda
🇬🇧Oxford, United Kingdom