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NCT Number: NCT02166736

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

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.

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Key information

Conditions

Angina Pectoris Acute Myocardial Infarction Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skejby University Hospital, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iFR

Device

Treatment guided by Instantaneous wave-free ratio (iFR®)

FFR

Device

Intervention guided by Fractional Flow Reserve

Primary outcomes

  1. All cause death, non-fatal Myocardial infarction (MI), Unplanned revascularization

    Time frame: 12 months

Secondary outcomes

  1. All cause death

    Time frame: 1-5 years

  2. Non-fatal MI

    Time frame: 1-5 years

  3. Unplanned revascularization

    Time frame: 1-5 years

  4. Target lesion revascularization

    Time frame: 1-5 years

  5. 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

  6. 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.

  7. Assessment of patient discomfort during the procedure (none/mild/moderate/severe

    Time frame: Day 1

  8. Procedural time

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study 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

Acronym: iFR Swedeheart

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 18, 2014
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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