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

Acute Myocardial Infarction Clinical Trial

— iFR Swedeheart  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166736
• Other study ID #: U-2013-044
• Status: Completed
• Phase: N/A
• First received: May 7, 2014
• Last updated: January 11, 2017
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2037
• Est. completion date: December 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Angina Pectoris
• Angina, Stable
• Infarction
• Myocardial Infarction

Intervention

Device:
• iFR
Treatment guided by Instantaneous wave-free ratio (iFR®)
• FFR
Intervention guided by Fractional Flow Reserve

Locations

Country	Name	City	State
Denmark	Skejby University Hospital	Aarhus
Iceland	Reykjavik University Hospital	Reykjavik
Sweden	Sahlgrenska University Hospital	Göteborg
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	S:t Göran County Hospital	Stockholm
Sweden	Sundsvall County Hospital	Sundsvall
Sweden	Uppsala University Hospital	Uppsala
Sweden	Västerås County Hospital	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Countries where clinical trial is conducted

Denmark,  Iceland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause death, non-fatal Myocardial infarction (MI), Unplanned revascularization		12 months	Yes
Secondary	All cause death		1-5 years	Yes
Secondary	Non-fatal MI		1-5 years	Yes
Secondary	Unplanned revascularization		1-5 years	Yes
Secondary	Target lesion revascularization		1-5 years	Yes
Secondary	Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions as reported in Swedish Coronary Angiography and Angioplasty Registry (SCAAR)		1-5 years	Yes
Secondary	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.	Day 1	No
Secondary	Assessment of patient discomfort during the procedure (none/mild/moderate/severe		Day 1	No
Secondary	Procedural time		Day 1	No