Coronary Artery DiseaseDEFINE-FLAIRNCT02053038
Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation
A study testing iFR and FFR in people with Coronary Artery Disease, run by Imperial College London at 50 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- iFR and FFR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 50 sitesin 17 countries
- Study dates
- Jan 2014to 19 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
50 sites in 17 countries.
50 sites in 17 countries
United Kingdom7 sites
Kare Tang
Basildon
Suneel Talwar
Bournemouth
Andrew Sharp
Exeter
Imperial College London
London
Ranil De Silva
London
Rajesh Kharbanda
Oxford
Robert Gerber
St Leonards
United States6 sites
Habib Samady
Atlanta, Georgia
Manesh Patel
Durham, North Carolina
John Altman
Lakewood, Colorado
Arnold Seto
Long Beach, California
Washington University School of Medicine
St Louis, Missouri, 63110
Allen Jeremias
Stony Brook, New York
Japan5 sites
Hiroaki Takashima
Aichi
Hiroyoshi Yokoi
Fukuoka
Yuetsu Kikuta
Fukuyama
Hitosh Matsuo
Gifu
Nob Tanaka
Tokyo
Australia4 sites
Sam Lehman
Adelaide
Darren Walters
Brisbane
James Sapontis
Melbourne
Ravinay Bhindi
Sydney
Germany4 sites
Florian Krackhardt
Berlin
Olaf Going
Berlin
Waldemar Bojara
Koblenz
Tobias Haerle
Oldenburg
South Korea4 sites
Chang-Wook Nam
Daegu
Joon-Hyung Doh
Daehwa
Bon-Kwon Koo
Seoul
Eun-Seok Shin
Ulsan
Italy3 sites
Ciro Indolfi
Catanzaro
Giampaolo Nicolli
Rome
Flavio Ribichini
Verona
Netherlands3 sites
Jan Piek
Amsterdam
Niels Van Royen
Amsterdam
Martijn Meuwissen
Breda
Portugal3 sites
Hugo Vinhas
Almada
Sergio Baptista
Amadora
Pedro Canas Silva
Lisbon
Spain3 sites
Salvatore Brugaletta
Barcelona
Clinico San Carlos
Madrid
Eduardo Alegria
Madrid
About this study
Official title: Prospective, Multi-center, Double Blind, Randomised Study to Test the Safety of Deferral of Stenting in Physiological Non-significant Lesions in a Clinical Population of Intermediate Stenoses Using iFR and FFR
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- iFR, FFR
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFRDevice
Treatment guided by instantaneous wave-free ratio
FFRDevice
Treatment guided by Fractional Flow Reserve
| Study group | Role | What they receive |
|---|---|---|
| iFR | Experimental | Treatment guided by iFR Receives: Device: iFR |
| FFR | Active comparator | Treatment guided by FFR Receives: Device: FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events
Composite of death, myocardial infarction, unplanned revascularisation
Measured: 30 days, 1, 2 and 5 years
Secondary outcomes (7)
Death (all cause)
Measured: 30 days, 1, 2 and 5 years
Death (cardiovascular)
Measured: 30 days, 1, 2 and 5 years
Myocardial Infarction
Measured: 30 days, 1, 2 and 5 years
Repeat revascularisation
Measured: 30 days, 1, 2 and 5 years
Cost associated to iFR or FFR measurement
Cost associated to iFR or FFR
Measured: 30 days, 1, 2 and 5 years
Quality of life assessed by EQ-5D-5L and Seattle Angina Questionnaire
Measured: 30 days, 1, 2 and 5 years
Cost savings of removing secondary investigations
- Cost savings of removing secondary investigations, by assessing/treating non-culprit acute coronary syndrome (ACS) at the time of index presentation.
Measured: 30 days, 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJan 2014
- Primary completion19 Jan 2021 (estimated)
- Study completion19 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Imperial College LondonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin ER Davies, MD, Principal investigator, Imperial College LondonJavier Escaned, MD, Principal investigator, Clinico San CarlosPatrick Serruys, MD, Study chair, Imperial College LondonManesh Patel, MD, Study chair, Duke UniversitySayan Sen, MD, Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053038
- Sponsor's protocol ID
- 13SM1797
- Acronym
- DEFINE-FLAIR
- Status last verified
- Aug 2019
- First submitted
- 26 Nov 2013
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
Escaned J, Travieso A, Dehbi HM, Nijjer SS, Sen S, Petraco R, Patel M, Serruys PW, Davies J; DEFINE FLAIR Investigators. Coronary Revascularization Guided With Fractional Flow Reserve or Instantaneous Wave-Free Ratio: A 5-Year Follow-Up of the DEFINE FLAIR Randomized Clinical Trial. JAMA Cardiol. 2025 Jan 1;10(1):25-31. doi: 10.1001/jamacardio.2024.3314.
PubMed 39412778Eftekhari A, Holck EN, Westra J, Olsen NT, Bruun NH, Jensen LO, Engstrom T, Christiansen EH. Instantaneous wave free ratio vs. fractional flow reserve and 5-year mortality: iFR SWEDEHEART and DEFINE FLAIR. Eur Heart J. 2023 Nov 1;44(41):4376-4384. doi: 10.1093/eurheartj/ehad582.
PubMed 37634144Kim CH, Koo BK, Dehbi HM, Lee JM, Doh JH, Nam CW, Shin ES, Cook CM, Al-Lamee R, Petraco R, Sen S, Malik IS, Nijjer SS, Mejia-Renteria H, Alegria-Barrero E, Alghamdi A, Altman J, Baptista SB, Bhindi R, Bojara W, Brugaletta S, Silva PC, Di Mario C, Erglis A, Gerber RT, Going O, Harle T, Hellig F, Indolfi C, Janssens L, Jeremias A, Kharbanda RK, Khashaba A, Kikuta Y, Krackhardt F, Laine M, Lehman SJ, Matsuo H, Meuwissen M, Niccoli G, Piek JJ, Ribichini F, Samady H, Sapontis J, Seto AH, Sezer M, Sharp ASP, Singh J, Takashima H, Talwar S, Tanaka N, Tang K, Van Belle E, van Royen N, Vinhas H, Vrints CJ, Walters D, Yokoi H, Samuels B, Buller C, Patel MR, Serruys PW, Escaned J, Davies JE. Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve-Guided Revascularization Strategy. JACC Cardiovasc Interv. 2019 Oct 28;12(20):2035-2046. doi: 10.1016/j.jcin.2019.06.035.
PubMed 31648764DEFINE-FLAIR Trial Investigators; Lee JM, Choi KH, Koo BK, Dehbi HM, Doh JH, Nam CW, Shin ES, Cook CM, Al-Lamee R, Petraco R, Sen S, Malik IS, Nijjer SS, Mejia-Renteria H, Alegria-Barrero E, Alghamdi A, Altman J, Baptista SB, Bhindi R, Bojara W, Brugaletta S, Silva PC, Di Mario C, Erglis A, Gerber RT, Going O, Harle T, Hellig F, Indolfi C, Janssens L, Jeremias A, Kharbanda RK, Khashaba A, Kikuta Y, Krackhardt F, Laine M, Lehman SJ, Matsuo H, Meuwissen M, Niccoli G, Piek JJ, Ribichini F, Samady H, Sapontis J, Seto AH, Sezer M, Sharp ASP, Singh J, Takashima H, Talwar S, Tanaka N, Tang K, Van Belle E, van Royen N, Vinhas H, Vrints CJ, Walters D, Yokoi H, Samuels B, Buller C, Patel MR, Serruys P, Escaned J, Davies JE. Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2019 Sep 1;4(9):857-864. doi: 10.1001/jamacardio.2019.2298.
PubMed 31314045Davies JE, Sen S, Dehbi HM, Al-Lamee R, Petraco R, Nijjer SS, Bhindi R, Lehman SJ, Walters D, Sapontis J, Janssens L, Vrints CJ, Khashaba A, Laine M, Van Belle E, Krackhardt F, Bojara W, Going O, Harle T, Indolfi C, Niccoli G, Ribichini F, Tanaka N, Yokoi H, Takashima H, Kikuta Y, Erglis A, Vinhas H, Canas Silva P, Baptista SB, Alghamdi A, Hellig F, Koo BK, Nam CW, Shin ES, Doh JH, Brugaletta S, Alegria-Barrero E, Meuwissen M, Piek JJ, van Royen N, Sezer M, Di Mario C, Gerber RT, Malik IS, Sharp ASP, Talwar S, Tang K, Samady H, Altman J, Seto AH, Singh J, Jeremias A, Matsuo H, Kharbanda RK, Patel MR, Serruys P, Escaned J. Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834. doi: 10.1056/NEJMoa1700445. Epub 2017 Mar 18.
PubMed 28317458
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Double Blind, Randomised Study to Test the Safety of Deferral of Stenting in Physiological Non-significant Lesions in a Clinical Population of Intermediate Stenoses Using iFR and FFR
- ClinicalTrials.gov ID
- NCT02053038
- Acronym / sponsor ID
- DEFINE-FLAIR / 13SM1797
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- 19 Jan 2021 (estimated)
- Study completion
- 19 Jan 2021 (estimated)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iFR | Experimental | Device: iFRTreatment guided by iFR |
| FFR | Active comparator | Device: FFRTreatment guided by FFR |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| iFRTreatment guided by instantaneous wave-free ratio | Device | iFR |
| FFRTreatment guided by Fractional Flow Reserve | Device | FFR |
Primary outcome
Major Adverse Cardiac Events
Time frame: 30 days, 1, 2 and 5 years
Composite of death, myocardial infarction, unplanned revascularisation
7 secondary outcomes
Death (all cause)
Time frame: 30 days, 1, 2 and 5 years
Death (cardiovascular)
Time frame: 30 days, 1, 2 and 5 years
Myocardial Infarction
Time frame: 30 days, 1, 2 and 5 years
Repeat revascularisation
Time frame: 30 days, 1, 2 and 5 years
Cost associated to iFR or FFR measurement
Time frame: 30 days, 1, 2 and 5 years
Quality of life assessed by EQ-5D-5L and Seattle Angina Questionnaire
Time frame: 30 days, 1, 2 and 5 years
Cost savings of removing secondary investigations
Time frame: 30 days, 1, 2 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Derived from this study: PubMed 39412778Escaned J, Travieso A, Dehbi HM, Nijjer SS, Sen S, Petraco R, Patel M, Serruys PW, Davies J; DEFINE FLAIR Investigators. Coronary Revascularization Guided With Fractional Flow Reserve or Instantaneous Wave-Free Ratio: A 5-Year Follow-Up of the DEFINE FLAIR Randomized Clinical Trial. JAMA Cardiol. 2025 Jan 1;10(1):25-31. doi: 10.1001/jamacardio.2024.3314.
- Derived from this study: PubMed 37634144Eftekhari A, Holck EN, Westra J, Olsen NT, Bruun NH, Jensen LO, Engstrom T, Christiansen EH. Instantaneous wave free ratio vs. fractional flow reserve and 5-year mortality: iFR SWEDEHEART and DEFINE FLAIR. Eur Heart J. 2023 Nov 1;44(41):4376-4384. doi: 10.1093/eurheartj/ehad582.
- Derived from this study: PubMed 31648764Kim CH, Koo BK, Dehbi HM, Lee JM, Doh JH, Nam CW, Shin ES, Cook CM, Al-Lamee R, Petraco R, Sen S, Malik IS, Nijjer SS, Mejia-Renteria H, Alegria-Barrero E, Alghamdi A, Altman J, Baptista SB, Bhindi R, Bojara W, Brugaletta S, Silva PC, Di Mario C, Erglis A, Gerber RT, Going O, Harle T, Hellig F, Indolfi C, Janssens L, Jeremias A, Kharbanda RK, Khashaba A, Kikuta Y, Krackhardt F, Laine M, Lehman SJ, Matsuo H, Meuwissen M, Niccoli G, Piek JJ, Ribichini F, Samady H, Sapontis J, Seto AH, Sezer M, Sharp ASP, Singh J, Takashima H, Talwar S, Tanaka N, Tang K, Van Belle E, van Royen N, Vinhas H, Vrints CJ, Walters D, Yokoi H, Samuels B, Buller C, Patel MR, Serruys PW, Escaned J, Davies JE. Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve-Guided Revascularization Strategy. JACC Cardiovasc Interv. 2019 Oct 28;12(20):2035-2046. doi: 10.1016/j.jcin.2019.06.035.
- Derived from this study: PubMed 31314045DEFINE-FLAIR Trial Investigators; Lee JM, Choi KH, Koo BK, Dehbi HM, Doh JH, Nam CW, Shin ES, Cook CM, Al-Lamee R, Petraco R, Sen S, Malik IS, Nijjer SS, Mejia-Renteria H, Alegria-Barrero E, Alghamdi A, Altman J, Baptista SB, Bhindi R, Bojara W, Brugaletta S, Silva PC, Di Mario C, Erglis A, Gerber RT, Going O, Harle T, Hellig F, Indolfi C, Janssens L, Jeremias A, Kharbanda RK, Khashaba A, Kikuta Y, Krackhardt F, Laine M, Lehman SJ, Matsuo H, Meuwissen M, Niccoli G, Piek JJ, Ribichini F, Samady H, Sapontis J, Seto AH, Sezer M, Sharp ASP, Singh J, Takashima H, Talwar S, Tanaka N, Tang K, Van Belle E, van Royen N, Vinhas H, Vrints CJ, Walters D, Yokoi H, Samuels B, Buller C, Patel MR, Serruys P, Escaned J, Davies JE. Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2019 Sep 1;4(9):857-864. doi: 10.1001/jamacardio.2019.2298.
- Derived from this study: PubMed 28317458Davies JE, Sen S, Dehbi HM, Al-Lamee R, Petraco R, Nijjer SS, Bhindi R, Lehman SJ, Walters D, Sapontis J, Janssens L, Vrints CJ, Khashaba A, Laine M, Van Belle E, Krackhardt F, Bojara W, Going O, Harle T, Indolfi C, Niccoli G, Ribichini F, Tanaka N, Yokoi H, Takashima H, Kikuta Y, Erglis A, Vinhas H, Canas Silva P, Baptista SB, Alghamdi A, Hellig F, Koo BK, Nam CW, Shin ES, Doh JH, Brugaletta S, Alegria-Barrero E, Meuwissen M, Piek JJ, van Royen N, Sezer M, Di Mario C, Gerber RT, Malik IS, Sharp ASP, Talwar S, Tang K, Samady H, Altman J, Seto AH, Singh J, Jeremias A, Matsuo H, Kharbanda RK, Patel MR, Serruys P, Escaned J. Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834. doi: 10.1056/NEJMoa1700445. Epub 2017 Mar 18.
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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.
Justin ER Davies, MD principal investigator
Imperial College London
Javier Escaned, MD principal investigator
Clinico San Carlos
Patrick Serruys, MD study chair
Imperial College London
50 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iFR and FFR in people with Coronary Artery Disease, run by Imperial College London at 50 sites in 17 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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United Kingdom, United States, Japan, Australia, Germany and 12 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?
Results are not available in the source record.
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?
Major Adverse Cardiac Events (time frame: 30 days, 1, 2 and 5 years). 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 NCT02053038, which also lists 5 linked publications.
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 14 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.