NCT02166736

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,037 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	iFR	Treatment guided by Instantaneous wave-free ratio (iFR®)
DEVICE	FFR	Intervention guided by Fractional Flow Reserve

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-10-01
• Completion: 2016-12-01
• First posted: 2014-06-18
• Last updated: 2017-01-12

Locations

14 sites across 3 countries: Denmark, Iceland, Sweden