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

January 11, 2017 updated by: Uppsala University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2037

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Skejby University Hospital
  • Iceland
      • Reykjavik, Iceland
        • Reykjavik University Hospital
  • Sweden
      • Göteborg, Sweden
        • Sahlgrenska University Hospital
      • Halmstad, Sweden
        • Halmstad sjukhus
      • Helsingborg, Sweden
        • Helsingborg County Hospital
      • Kalmar, Sweden
        • Kalmar County Hospital
      • Karlstad, Sweden
        • Karlstad County Hospital
      • Linköping, Sweden
        • Linkoping University Hospital
      • Lund, Sweden
        • Skåne University Hospital
      • Stockholm, Sweden
        • S:t Göran County Hospital
      • Sundsvall, Sweden
        • Sundsvall County Hospital
      • Uppsala, Sweden
        • Uppsala University Hospital
      • Västerås, Sweden
        • Västerås County Hospital
      • Örebro, Sweden
        • Orebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause death, non-fatal Myocardial infarction (MI), Unplanned revascularization
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause death
Time Frame: 1-5 years
1-5 years
Non-fatal MI
Time Frame: 1-5 years
1-5 years
Unplanned revascularization
Time Frame: 1-5 years
1-5 years
Target lesion revascularization
Time Frame: 1-5 years
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
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.
Day 1
Assessment of patient discomfort during the procedure (none/mild/moderate/severe
Time Frame: Day 1
Day 1
Procedural time
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 7, 2014

First Submitted That Met QC Criteria

June 14, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U-2013-044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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