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Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome (iFR Swedeheart)

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ClinicalTrials.gov Identifier: NCT02166736
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Tracking Information
First Submitted Date  ICMJE May 7, 2014
First Posted Date  ICMJE June 18, 2014
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE May 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2014)
All cause death, non-fatal Myocardial infarction (MI), Unplanned revascularization [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
  • All cause death [ Time Frame: 1-5 years ]
  • Non-fatal MI [ Time Frame: 1-5 years ]
  • Unplanned revascularization [ Time Frame: 1-5 years ]
  • Target lesion revascularization [ Time Frame: 1-5 years ]
  • Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions as reported in Swedish Coronary Angiography and Angioplasty Registry (SCAAR) [ Time Frame: 1-5 years ]
  • Change in physician´s treatment strategy depending on iFR/FFR information [ Time Frame: Day 1 ]
    Before randomization, the operators will have to record their angiographic assessment of the coronary lesions and the theoretical treatment strategy based on the angiographic information alone. After randomization and functional assessment of lesion severity, the operators will record how iFR/FFR changed the treatment strategy.
  • Assessment of patient discomfort during the procedure (none/mild/moderate/severe [ Time Frame: Day 1 ]
  • Procedural time [ Time Frame: Day 1 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2014)
  • All cause death [ Time Frame: 1-5 years ]
  • Non-fatal MI [ Time Frame: 1-5 years ]
  • Unplanned revascularization [ Time Frame: 1-5 years ]
  • Target lesion revascularization [ Time Frame: 1-5 years ]
  • Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions as reported in Swedish Coronary Angiography and Angioplasty Registry (SCAAR) [ Time Frame: 1-5 years ]
  • Change in physician´s treatment strategy depending on iFR/FFR information [ Time Frame: Day of procedure ]
    Before randomization, the operators will have to record their angiographic assessment of the coronary lesions and the theoretical treatment strategy based on the angiographic information alone. After randomization and functional assessment of lesion severity, the operators will record how iFR/FFR changed the treatment strategy.
  • Assessment of patient discomfort during the procedure (none/mild/moderate/severe [ Time Frame: Day of procedure ]
  • Procedural time [ Time Frame: Day of procedure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome
Official Title  ICMJE Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome. A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the Swedish Angiography and Angioplasty Registry (SWEDEHEART) Platform
Brief Summary

Previous trials have demonstrated that the use of physiological assessment of stenosis severity using fractional flow reserve (FFR) is superior to angiographic assessment in percutaneous coronary intervention (PCI) and improves clinical outcome. Despite the clinical utility, FFR is used only in 10-15% of patients today. The main reasons for the low adoption rate of FFR are the prolonged procedural time, Adenosine related discomfort and cost associated with Adenosine.

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Angina Pectoris
  • Acute Myocardial Infarction
Intervention  ICMJE
  • Device: iFR
    Treatment guided by Instantaneous wave-free ratio (iFR®)
  • Device: FFR
    Intervention guided by Fractional Flow Reserve
Study Arms  ICMJE
  • Experimental: Instantaneous wave-free ratio (iFR)
    Intervention: Device: iFR
  • Active Comparator: Fractional Flow Reserve (FFR)
    Intervention: Device: FFR
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2017)
2037
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2014)
2000
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with suspected stable angina pectoris or unstable angina pectoris/non-ST-segment elevation myocardial infarction (NSTEMI) who are scheduled to undergo coronary angiography, and who has an indication for physiology guided assessment of coronary lesions (usually 30-80% stenosis grade). In patients with suspected stable angina pectoris, any lesion may be assessed. In patients with unstable angina pectoris/NSTEMI, only the non-culprit lesion may be assessed.

Exclusion Criteria:

  • Inability to provide informed consent
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Iceland,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02166736
Other Study ID Numbers  ICMJE U-2013-044
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias Götberg, MD,PhD Department of Cardiology, Skane University Hospital, Lund University, Lund, Sweden
Study Chair: Ole Fröbert, Prof Department of Cardiology, Örebro University Hospital, Örebro, Sweden
PRS Account Uppsala University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP