MedTrace Logo

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

NCT02166736 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2037

Last updated 2017-01-12

No results posted yet for this study

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.

Conditions

  • Angina Pectoris
  • Acute Myocardial Infarction

Interventions

DEVICE

iFR

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

DEVICE

FFR

Intervention guided by Fractional Flow Reserve

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Matthias Götberg, MD,PhD · Department of Cardiology, Skane University Hospital, Lund University, Lund, Sweden

  • Ole Fröbert, Prof · Department of Cardiology, Örebro University Hospital, Örebro, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-10-31
Completion
2016-12-31

Countries

  • Denmark
  • Iceland
  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02166736 on ClinicalTrials.gov