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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT02166736
First received: May 7, 2014
Last updated: January 11, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention
Angina Pectoris
Acute Myocardial Infarction
Device: iFR
Device: FFR

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • All cause death, non-fatal Myocardial infarction (MI), Unplanned revascularization [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2037
Study Start Date: May 2014
Study Completion Date: December 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Instantaneous wave-free ratio (iFR) Device: iFR
Treatment guided by Instantaneous wave-free ratio (iFR®)
Active Comparator: Fractional Flow Reserve (FFR) Device: FFR
Intervention guided by Fractional Flow Reserve

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02166736

Locations
Denmark
Skejby University Hospital
Aarhus, Denmark
Iceland
Reykjavik University Hospital
Reykjavik, Iceland
Sweden
Sahlgrenska University Hospital
Göteborg, 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
S:t Göran County Hospital
Stockholm, Sweden
Sundsvall County Hospital
Sundsvall, Sweden
Uppsala University Hospital
Uppsala, Sweden
Västerås County Hospital
Västerås, Sweden
Örebro University Hospital
Örebro, Sweden
Sponsors and Collaborators
Uppsala University
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02166736     History of Changes
Other Study ID Numbers: U-2013-044 
Study First Received: May 7, 2014
Last Updated: January 11, 2017

Keywords provided by Uppsala University:
Instantaneous wave Free Ratio
Fractional Flow Reserve

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Angina Pectoris
Acute Coronary Syndrome
Angina, Stable
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on January 19, 2017