Fractional Flow Reserve Versus Angiographically Guided Management to Optimise Outcomes in Unstable Coronary Syndromes

NCT01764334 | Unknown Phase 4 DMC

• 2 other identifiers: NRS-11-CA56PG/11/55/28999
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 6

Brief Summary

Background: In patients with acute non-ST elevation myocardial infarction (NSTEMI) coronary arteriography is usually recommended however visual interpretation of the coronary angiogram is subjective. A complementary diagnostic approach involves measuring the pressure drop across a coronary stenosis (fractional flow reserve, FFR) with a pressure-sensitive guidewire. Hypothesis: Routine FFR measurement is feasible in NSTEMI patients and has additive diagnostic, clinical and health economic utility, as compared to angiography-guided standard care. Design: A prospective multi-center randomized controlled trial in 350 NSTEMI patients with ≥1 coronary stenosis ≥30% severity (threshold for FFR measurement). Patients will be randomized immediately after coronary angiography to the FFR-guided group or angiography-guided group (FFR measured, not disclosed). All patients will then undergo FFR measurement in all vessels with a coronary stenosis ≥30% severity. FFR will be measured in culprit and non-culprit lesions in all patients. FFR will be disclosed to guide treatment in the FFR guided-group but not disclosed in the 'angiography-guided' group. In the FFR-guided group, an FFR\>0.80 will be an indication for medical therapy whereas an FFR≤0.80 will be an indication for revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG), as appropriate. The primary endpoint is the between-group difference in the proportion of patients allocated to medical management compared to revascularization. A key secondary composite outcome is the occurrence of cardiac death or hospitalization for myocardial infarction or heart failure. Other secondary outcomes include quality of life, hospitalization for unstable angina, coronary revascularization or stroke, and healthcare costs. Exploratory analyses will also assess the relationships between FFR and angiographic lesion characteristics (severity, culprit status). The minimum and average follow-up periods for the primary analysis are 6 and 18 months respectively. A secondary analysis with longer term follow-up (minimum 3 years) is planned. Screen failures who gave informed consent will be entered into a registry. Importance: Our developmental clinical trial will address the feasibility of FFR measurement in NSTEMI and the influence of FFR disclosure on treatment decisions and health and economic outcomes.

Conditions

NonST Elevation Myocardial Infarction; Myocardial Infarction

Keywords

NonST elevation myocardial infarction (NSTEMI); Fractional flow reserve (FFR); Coronary angiogram; Diagnosis; Coronary revascularization; Prognosis; Health economics

Outcome Measures

Primary Outcomes (1)

• The between-group difference in the proportion of patients allocated to medical management compared to revascularization.

  The between-group difference in the proportion of patients allocated to medical management compared to coronary revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG).

  Baseline: the treatment decision will be made by the clinical team in the cardiac catheter laboratory during the index procedure or shortly afterwards during the index hospitalization when a multidisciplinary heart team review is indicated.

Secondary Outcomes (5)

• The safety and feasibility of routine FFR measurement in patients with recent NSTEMI.

  Post randomization index procedure at baseline.

• The % rate of discordance between an FFR <= or >0.80 and coronary stenosis severity (stenosis > or <70% of reference vessel diameter (50% for left main) assessed visually).

  Baseline: Visual assessment of the angiogram before randomization, index procedure

• Major adverse cardiac events are defined as cardiac death or hospitalization for myocardial infarction (MI) or heart failure.

  Post-randomization (any time including the index procedure through follow-up), expected average follow-up of 18 months (minimum follow-up 6 months).

• Health economics

  Post-randomization (including the index procedure through longer term mean follow-up of 18 months (minimum follow-up 6 months).

• Quality of life

  Baseline through longer term follow-up (average follow-up 18 months, minimum follow-up 6 months)

Study Arms (2)

Fractional flow reserve

ACTIVE COMPARATOR

Fractional flow reserve - guided group: The initial treatment decision and the coronary arteries for fractional flow reserve (FFR) measurement will be established and recorded before randomization. FFR will then be measured by the cardiologist immediately after randomization and the FFR result will used to guide treatment decisions based on a threshold of 0.80. An FFR ≤ 0.80 should result in a treatment decision for revascularization by PCI or CABG combined with optimal medical therapy and an FFR\>0.80 should result in treatment with optimal medical therapy alone. Changes in treatment compared to the treatment plan prior to FFR disclosure will be recorded at the time.

Device: Fractional flow reserve

Angiography-guided

PLACEBO COMPARATOR

FFR is measured by but not disclosed to the clinical team. Treatment decisions are therefore guided by angiography but not by FFR. The patient and the clinical team, including the cardiologists and nurses, will be blinded to FFR. The RadiAnalyzer Xpress (St Jude Medical) will be turned away from the clinical team who will not see the pressure wire data. FFR will not be displayed on any other monitor. Quality control checks, such as assessments of equalized pressure, will be done in the usual way, by the unblinded clinical research team. These steps will be followed for all FFR measurements. Adherence to the blinding protocol, including any non-protocol FFR disclosure at any time, will be prospectively recorded and blinding procedures will be monitored with site visits.

Device: Fractional flow reserve

Interventions

Fractional flow reserve DEVICE

Guidewire-based coronary pressure measurement of myocardial FFR can identify obstructive coronary lesions in patients with stable coronary disease, and potentially, medically stabilized patients with recent MI. The FFR index is measured by a conventional coronary wire (0.014") with a pressure sensor on its distal tip during coronary hyperemia induced by intravenous or intracoronary adenosine. The potential diagnostic and prognostic benefit of guidewire-based coronary pressure measurement to inform the management and treatment of patients with recent acute NSTEMI will be assessed.

Also known as: FFR, Pressure wire

Angiography-guided; Fractional flow reserve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NSTEMI with an elevated troponin (\> upper limit of normal for local reference range) with at least one CAD risk factor (e.g. diabetes, age \> 65 years, prior CAD, prior peripheral vascular disease, hypertension, hyperlipidaemia, family history of CAD).
• At least one coronary lesion ≥ 30% stenosis severity.
• Invasive management scheduled within 10 days of admission and ideally performed within 72 h of admission or a history of recurrent ischemic symptoms within 5 days.

You may not qualify if:

• On-going ischemic symptoms (i.e. chest pain) not controlled by medical therapy.
• Cardiogenic shock or hemodynamic instability.
• Life expectancy of \< 1 year.
• MI with persistent ST elevation.
• Intolerance to anti-platelet drugs.
• Unsuitable for either PCI or CABG on clinical or angiographic grounds.
• Coronary artery disease \< 30% reference vessel diameter.
• Absence of a non-flow limiting coronary stenosis ≥30%.
• Non-coronary cardiac surgery (e.g. concomitant valve repair or replacement).
• Inability to give informed consent.
• Age \< 18 years (no upper age limit).

Sponsors & Collaborators

• NHS National Waiting Times Centre Board: lead
• British Heart Foundation: collaborator
• Abbott Medical Devices: collaborator
• University of Glasgow: collaborator

Study Sites (6)

Golden Jubilee National Hospital

Clydebank, Dunbartonshire, G81 4DY, United Kingdom

Location

Royal Blackburn Hospital

Blackburn, East Lancashire, BB2 3HH, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, S016 6YD, United Kingdom

Location

Hairmyres Hospital

East Kilbride, Lanarkshire, G75 8RG, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

Location

City Hospitals Sunderland NHS Foundation

Sunderland, Tyne and Wear, SR4 7TP, United Kingdom

Location

Related Publications (31)

• Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. No abstract available.

  PMID: 21873419 BACKGROUND

• Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI); Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010 Oct;31(20):2501-55. doi: 10.1093/eurheartj/ehq277. Epub 2010 Aug 29. No abstract available.

  PMID: 20802248 BACKGROUND

• Selby JV, Fireman BH, Lundstrom RJ, Swain BE, Truman AF, Wong CC, Froelicher ES, Barron HV, Hlatky MA. Variation among hospitals in coronary-angiography practices and outcomes after myocardial infarction in a large health maintenance organization. N Engl J Med. 1996 Dec 19;335(25):1888-96. doi: 10.1056/NEJM199612193352506.

  PMID: 8948565 BACKGROUND

• White CW, Wright CB, Doty DB, Hiratza LF, Eastham CL, Harrison DG, Marcus ML. Does visual interpretation of the coronary arteriogram predict the physiologic importance of a coronary stenosis? N Engl J Med. 1984 Mar 29;310(13):819-24. doi: 10.1056/NEJM198403293101304.

  PMID: 6700670 BACKGROUND

• Botman KJ, Pijls NH, Bech JW, Aarnoudse W, Peels K, van Straten B, Penn O, Michels HR, Bonnier H, Koolen JJ. Percutaneous coronary intervention or bypass surgery in multivessel disease? A tailored approach based on coronary pressure measurement. Catheter Cardiovasc Interv. 2004 Oct;63(2):184-91. doi: 10.1002/ccd.20175.

  PMID: 15390344 BACKGROUND

• Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW, van't Veer M, Bar F, Hoorntje J, Koolen J, Wijns W, de Bruyne B. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. 2007 May 29;49(21):2105-11. doi: 10.1016/j.jacc.2007.01.087. Epub 2007 May 17.

  PMID: 17531660 BACKGROUND

• Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

  PMID: 19144937 BACKGROUND

• De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.

  PMID: 22924638 BACKGROUND

• Fearon WF, Bornschein B, Tonino PA, Gothe RM, Bruyne BD, Pijls NH, Siebert U; Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) Study Investigators. Economic evaluation of fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. Circulation. 2010 Dec 14;122(24):2545-50. doi: 10.1161/CIRCULATIONAHA.109.925396. Epub 2010 Nov 29.

  PMID: 21126973 BACKGROUND

• Bech GJ, Droste H, Pijls NH, De Bruyne B, Bonnier JJ, Michels HR, Peels KH, Koolen JJ. Value of fractional flow reserve in making decisions about bypass surgery for equivocal left main coronary artery disease. Heart. 2001 Nov;86(5):547-52. doi: 10.1136/heart.86.5.547.

  PMID: 11602550 BACKGROUND

• De Bruyne B, Pijls NH, Bartunek J, Kulecki K, Bech JW, De Winter H, Van Crombrugge P, Heyndrickx GR, Wijns W. Fractional flow reserve in patients with prior myocardial infarction. Circulation. 2001 Jul 10;104(2):157-62. doi: 10.1161/01.cir.104.2.157.

  PMID: 11447079 BACKGROUND

• Tonino PA, Fearon WF, De Bruyne B, Oldroyd KG, Leesar MA, Ver Lee PN, Maccarthy PA, Van't Veer M, Pijls NH. Angiographic versus functional severity of coronary artery stenoses in the FAME study fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol. 2010 Jun 22;55(25):2816-21. doi: 10.1016/j.jacc.2009.11.096.

  PMID: 20579537 BACKGROUND

• Uren NG, Crake T, Lefroy DC, de Silva R, Davies GJ, Maseri A. Reduced coronary vasodilator function in infarcted and normal myocardium after myocardial infarction. N Engl J Med. 1994 Jul 28;331(4):222-7. doi: 10.1056/NEJM199407283310402.

  PMID: 7832835 BACKGROUND

• Ntalianis A, Sels JW, Davidavicius G, Tanaka N, Muller O, Trana C, Barbato E, Hamilos M, Mangiacapra F, Heyndrickx GR, Wijns W, Pijls NH, De Bruyne B. Fractional flow reserve for the assessment of nonculprit coronary artery stenoses in patients with acute myocardial infarction. JACC Cardiovasc Interv. 2010 Dec;3(12):1274-81. doi: 10.1016/j.jcin.2010.08.025.

  PMID: 21232721 BACKGROUND

• Potvin JM, Rodes-Cabau J, Bertrand OF, Gleeton O, Nguyen CN, Barbeau G, Proulx G, De Larochelliere R, Dery JP, Batalla N, Dana A, Facta A, Roy L. Usefulness of fractional flow reserve measurements to defer revascularization in patients with stable or unstable angina pectoris, non-ST-elevation and ST-elevation acute myocardial infarction, or atypical chest pain. Am J Cardiol. 2006 Aug 1;98(3):289-97. doi: 10.1016/j.amjcard.2006.02.032. Epub 2006 Jun 6.

  PMID: 16860011 BACKGROUND

• Leesar MA, Abdul-Baki T, Akkus NI, Sharma A, Kannan T, Bolli R. Use of fractional flow reserve versus stress perfusion scintigraphy after unstable angina. Effect on duration of hospitalization, cost, procedural characteristics, and clinical outcome. J Am Coll Cardiol. 2003 Apr 2;41(7):1115-21. doi: 10.1016/s0735-1097(03)00057-3.

  PMID: 12679210 BACKGROUND

• Sels JW, Tonino PA, Siebert U, Fearon WF, Van't Veer M, De Bruyne B, Pijls NH. Fractional flow reserve in unstable angina and non-ST-segment elevation myocardial infarction experience from the FAME (Fractional flow reserve versus Angiography for Multivessel Evaluation) study. JACC Cardiovasc Interv. 2011 Nov;4(11):1183-9. doi: 10.1016/j.jcin.2011.08.008.

  PMID: 22115657 BACKGROUND

• Rosner GF, Kirtane AJ, Genereux P, Lansky AJ, Cristea E, Gersh BJ, Weisz G, Parise H, Fahy M, Mehran R, Stone GW. Impact of the presence and extent of incomplete angiographic revascularization after percutaneous coronary intervention in acute coronary syndromes: the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. Circulation. 2012 May 29;125(21):2613-20. doi: 10.1161/CIRCULATIONAHA.111.069237. Epub 2012 May 1.

  PMID: 22550156 BACKGROUND

• Carrick D, Behan M, Foo F, Christie J, Hillis WS, Norrie J, Oldroyd KG, Berry C. Usefulness of fractional flow reserve to improve diagnostic efficiency in patients with non-ST elevation myocardial infarction. Am J Cardiol. 2013 Jan 1;111(1):45-50. doi: 10.1016/j.amjcard.2012.08.046. Epub 2012 Oct 2.

  PMID: 23040601 BACKGROUND

• Balachandran KP, Berry C, Norrie J, Vallance BD, Malekianpour M, Gilbert TJ, Pell AC, Oldroyd KG. Relation between coronary pressure derived collateral flow, myocardial perfusion grade, and outcome in left ventricular function after rescue percutaneous coronary intervention. Heart. 2004 Dec;90(12):1450-4. doi: 10.1136/hrt.2003.023606.

  PMID: 15547027 BACKGROUND

• Berry C, Layland J, Sood A, Curzen NP, Balachandran KP, Das R, Junejo S, Henderson RA, Briggs AH, Ford I, Oldroyd KG. Fractional flow reserve versus angiography in guiding management to optimize outcomes in non-ST-elevation myocardial infarction (FAMOUS-NSTEMI): rationale and design of a randomized controlled clinical trial. Am Heart J. 2013 Oct;166(4):662-668.e3. doi: 10.1016/j.ahj.2013.07.011. Epub 2013 Aug 27.

  PMID: 24093845 BACKGROUND

• Layland J, Berry C. Intracoronary Adenosine for Maximal Hyperemia: Less Is More...More or Less? JACC Cardiovasc Interv. 2015 Sep;8(11):1431-1432. doi: 10.1016/j.jcin.2015.04.027. No abstract available.

  PMID: 26404194 BACKGROUND

• Layland J, Nerlekar N, Palmer S, Berry C, Oldroyd K. Invasive assessment of the coronary microcirculation in the catheter laboratory. Int J Cardiol. 2015 Nov 15;199:141-9. doi: 10.1016/j.ijcard.2015.05.190. Epub 2015 Jul 8.

  PMID: 26197399 BACKGROUND

• Layland J, Carrick D, McEntegart M, Ahmed N, Payne A, McClure J, Sood A, McGeoch R, MacIsaac A, Whitbourn R, Wilson A, Oldroyd K, Berry C. Vasodilatory capacity of the coronary microcirculation is preserved in selected patients with non-ST-segment-elevation myocardial infarction. Circ Cardiovasc Interv. 2013 Jun;6(3):231-6. doi: 10.1161/CIRCINTERVENTIONS.112.000180. Epub 2013 Jun 11.

  PMID: 23756697 BACKGROUND

• Layland J, Rauhalammi S, Lee MM, Ahmed N, Carberry J, Teng Yue May V, Watkins S, McComb C, Mangion K, McClure JD, Carrick D, O'Donnell A, Sood A, McEntegart M, Oldroyd KG, Radjenovic A, Berry C. Diagnostic Accuracy of 3.0-T Magnetic Resonance T1 and T2 Mapping and T2-Weighted Dark-Blood Imaging for the Infarct-Related Coronary Artery in Non-ST-Segment Elevation Myocardial Infarction. J Am Heart Assoc. 2017 Mar 31;6(4):e004759. doi: 10.1161/JAHA.116.004759.

  PMID: 28364045 RESULT

• Nam J, Briggs A, Layland J, Oldroyd KG, Curzen N, Sood A, Balachandran K, Das R, Junejo S, Eteiba H, Petrie MC, Lindsay M, Watkins S, Corbett S, O'Rourke B, O'Donnell A, Stewart A, Hannah A, McConnachie A, Henderson R, Berry C. Fractional flow reserve (FFR) versus angiography in guiding management to optimise outcomes in non-ST segment elevation myocardial infarction (FAMOUS-NSTEMI) developmental trial: cost-effectiveness using a mixed trial- and model-based methods. Cost Eff Resour Alloc. 2015 Nov 14;13:19. doi: 10.1186/s12962-015-0045-9. eCollection 2015.

  PMID: 26578850 RESULT

• Ahmed N, Layland J, Carrick D, Petrie MC, McEntegart M, Eteiba H, Hood S, Lindsay M, Watkins S, Davie A, Mahrous A, Carberry J, Teng V, McConnachie A, Curzen N, Oldroyd KG, Berry C. Safety of guidewire-based measurement of fractional flow reserve and the index of microvascular resistance using intravenous adenosine in patients with acute or recent myocardial infarction. Int J Cardiol. 2016 Jan 1;202:305-10. doi: 10.1016/j.ijcard.2015.09.014. Epub 2015 Sep 18.

  PMID: 26418191 RESULT

• Layland J, Rauhalammi S, Watkins S, Ahmed N, McClure J, Lee MM, Carrick D, O'Donnell A, Sood A, Petrie MC, May VT, Eteiba H, Lindsay M, McEntegart M, Oldroyd KG, Radjenovic A, Berry C. Assessment of Fractional Flow Reserve in Patients With Recent Non-ST-Segment-Elevation Myocardial Infarction: Comparative Study With 3-T Stress Perfusion Cardiac Magnetic Resonance Imaging. Circ Cardiovasc Interv. 2015 Aug;8(8):e002207. doi: 10.1161/CIRCINTERVENTIONS.114.002207.

  PMID: 26253733 RESULT

• Berry C, Corcoran D, Hennigan B, Watkins S, Layland J, Oldroyd KG. Fractional flow reserve-guided management in stable coronary disease and acute myocardial infarction: recent developments. Eur Heart J. 2015 Dec 1;36(45):3155-64. doi: 10.1093/eurheartj/ehv206. Epub 2015 Jun 2.

  PMID: 26038588 RESULT

• Layland J, Oldroyd KG, Curzen N, Sood A, Balachandran K, Das R, Junejo S, Ahmed N, Lee MM, Shaukat A, O'Donnell A, Nam J, Briggs A, Henderson R, McConnachie A, Berry C; FAMOUS-NSTEMI investigators. Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS-NSTEMI randomized trial. Eur Heart J. 2015 Jan 7;36(2):100-11. doi: 10.1093/eurheartj/ehu338. Epub 2014 Sep 1.

  PMID: 25179764 RESULT

• Layland J, Carrick D, Lee M, Oldroyd K, Berry C. Adenosine: physiology, pharmacology, and clinical applications. JACC Cardiovasc Interv. 2014 Jun;7(6):581-91. doi: 10.1016/j.jcin.2014.02.009. Epub 2014 May 14.

  PMID: 24835328 RESULT

Related Links

• Institute of Cardiovascular and Medical Sciences, University of Glasgow
• British Heart Foundation

MeSH Terms

Conditions

Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Colin Berry, MD PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

• Robert Henderson, MD FRCP

  Nottingham University Hospitals, Nottingham, UK

  STUDY CHAIR

• Ian Ford, PhD

  Robertson Centre for Biostatistics - University of Glasgow

  STUDY DIRECTOR

• Andrew Briggs, PhD

  Health Economics and Health Technology Assessment, University of Glasgow

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of FFR result
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Colin Berry

Model Details: Diagnostic intervention using fractional flow reserve

Study Record Dates

• First Submitted: December 24, 2012
• First Posted: January 9, 2013
• Study Start: October 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2020
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (6)