Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome
NCT ID: NCT02166736
Last Updated: 2017-01-12
Study Results
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Basic Information
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COMPLETED
NA
2037 participants
INTERVENTIONAL
2014-05-31
2016-12-31
Brief Summary
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Instantaneous Wave-Free ratio (iFR®) is a novel method to assess coronary lesions for functional significance. The main benefits of the method compared to FFR are that the measurement is instantaneous and does not require Adenosine infusion. Thus, the patient does not experience any discomfort from the measurement and procedural time could be shortened compared to when using FFR. This could potentially increase the adoption rate of physiologic assessment of coronary lesions.
The aim of this trial is to compare the clinical outcome of patients assessed by iFR® with patients assessed by FFR.
Furthermore, the trial will be conducted as a registry based randomized clinical trial (RRCT) which is a novel strategy to conduct clinical trials. The randomization will occur online in the Swedish angiography and angioplasty registry (SWEDEHEART) using a web based platform.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Instantaneous wave-free ratio (iFR)
iFR
Treatment guided by Instantaneous wave-free ratio (iFR®)
Fractional Flow Reserve (FFR)
FFR
Intervention guided by Fractional Flow Reserve
Interventions
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iFR
Treatment guided by Instantaneous wave-free ratio (iFR®)
FFR
Intervention guided by Fractional Flow Reserve
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Age below 18 years
* Previous randomization in the iFR-SWEDEHEART trial
* Known terminal disease with a life expectancy of less than one year.
* In patients with multi-vessel disease and other indication than stable angina pectoris, difficulty in assessing which the culprit lesion is.
* Patient with unstable hemodynamics (Killip class III-IV)
* Inability to tolerate Adenosine
* Previous Coronary artery bypass graft (CABG) with patent grafts to the interrogated vessel.
* Heavily calcified or tortuous vessel where inability to cross the lesion with a pressure wire is expected.
18 Years
99 Years
ALL
No
Sponsors
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Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Matthias Götberg, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Skane University Hospital, Lund University, Lund, Sweden
Ole Fröbert, Prof
Role: STUDY_CHAIR
Department of Cardiology, Örebro University Hospital, Örebro, Sweden
Locations
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Skejby University Hospital
Aarhus, , Denmark
Reykjavik University Hospital
Reykjavik, , Iceland
Sahlgrenska University Hospital
Gothenburg, , Sweden
Halmstad sjukhus
Halmstad, , Sweden
Helsingborg County Hospital
Helsingborg, , Sweden
Kalmar County Hospital
Kalmar, , Sweden
Karlstad County Hospital
Karlstad, , Sweden
Linköping University Hospital
Linköping, , Sweden
Skane University Hospital
Lund, , Sweden
Örebro University Hospital
Örebro, , Sweden
S:t Göran County Hospital
Stockholm, , Sweden
Sundsvall County Hospital
Sundsvall, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Västerås County Hospital
Västerås, , Sweden
Countries
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References
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Eftekhari 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.
Berntorp K, Rylance R, Yndigegn T, Koul S, Frobert O, Christiansen EH, Erlinge D, Gotberg M. Clinical Outcome of Revascularization Deferral With Instantaneous Wave-Free Ratio and Fractional Flow Reserve: A 5-Year Follow-Up Substudy From the iFR-SWEDEHEART Trial. J Am Heart Assoc. 2023 Feb 7;12(3):e028423. doi: 10.1161/JAHA.122.028423. Epub 2023 Feb 3.
Gotberg M, Berntorp K, Rylance R, Christiansen EH, Yndigegn T, Gudmundsdottir IJ, Koul S, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Venetsanos D, James SK, Karegren A, Carlsson J, Jensen J, Karlsson AC, Erlinge D, Frobert O. 5-Year Outcomes of PCI Guided by Measurement of Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve. J Am Coll Cardiol. 2022 Mar 15;79(10):965-974. doi: 10.1016/j.jacc.2021.12.030.
Gotberg M, Christiansen EH, Gudmundsdottir IJ, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Ohagen P, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Todt T, Venetsanos D, James SK, Karegren A, Nilsson M, Carlsson J, Hauer D, Jensen J, Karlsson AC, Panayi G, Erlinge D, Frobert O; iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823. doi: 10.1056/NEJMoa1616540. Epub 2017 Mar 18.
Gotberg M, Christiansen EH, Gudmundsdottir I, Sandhall L, Omerovic E, James SK, Erlinge D, Frobert O. Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial. Am Heart J. 2015 Nov;170(5):945-50. doi: 10.1016/j.ahj.2015.07.031. Epub 2015 Aug 15.
Other Identifiers
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U-2013-044
Identifier Type: -
Identifier Source: org_study_id
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