Overview

This trial is active, not recruiting.

Conditions angina pectoris, acute myocardial infarction
Treatments ifr, ffr
Sponsor Uppsala University
Start date May 2014
End date October 2015
Trial size 2000 participants
Trial identifier NCT02166736, U-2013-044

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
ifr
Treatment guided by Instantaneous wave-free ratio (iFR®)
(Active Comparator)
ffr
Intervention guided by Fractional Flow Reserve

Primary Outcomes

Measure
All cause death, non-fatal Myocardial infarction (MI), Unplanned revascularization
time frame: 12 months

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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.

Additional Information

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
Principal investigator Matthias Götberg, MD,PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Uppsala University.