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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,037
Skejby University Hospital
Aarhus, Denmark
Reykjavik University Hospital
Reykjavik, Iceland
Sahlgrenska University Hospital
Gothenburg, 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
Örebro University Hospital
Örebro, Sweden
...and 4 more locations
All cause death, non-fatal Myocardial infarction (MI), Unplanned revascularization
Time frame: 12 months
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
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.
Time frame: Day 1
Assessment of patient discomfort during the procedure (none/mild/moderate/severe
Time frame: Day 1
Procedural time
Time frame: Day 1
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