PIONEER IV Version 1 28 April 2021
Research type
Research Study
Full title
Non-inferiority of angiography-derived physiology guidance versus usual care in an All-comers PCI population treated with unrestricted use of the Healing-Targeted Supreme (HT SupremeTM) drug-eluting stent and P2Y12 inhibitor monotherapy after 1-month of dual-antiplatelet therapy: the PIONEER IV trial
IRAS ID
302075
Contact name
Andreas Baumbach
Contact email
Sponsor organisation
National University of Ireland, Galway
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 1 days
Research summary
This Study is a prospective, single-blind (patient), randomized, 1:1,controlled, multi-centre study to compare the Patient outcomes at 12 months post procedure in an all-comers population (including High Bleeding Risk patients) when treated by Percutaneous Coronary Intervention (PCI) with unrestricted use of the HT Supreme sirolimus-eluting stent, and receiving post PCI one month Duel Antiplatelet Therapy (DAPT) followed by 11-month of P2Y12 inhibitor monotherapy when using either guidance based on angiography derived physiology (Quantitative Flow Ratio, QFR) (1270 Patients) or local routine diagnostic procedure (LRDP) (1270 Patients).
The European Society of Cardiology guidelines 2019 on chronic coronary syndrome recommend mandatory physiological assessment for localization of ischemia in patients with multi-vessel disease, even after ischemia is proven by a non-invasive test. FFR (Fractional Flow Reserve) guided PCI with medical therapy, as compared with medical therapy alone, improved the clinical outcome in patients having at least one stenosis. However, the functional assessment by FFR is cumbersome the evaluation requires maximal and stable hyperaemia, which is usually obtained by the administration of intravenous adenosine. iFR (Instant Wave Free Ratio) on the other hand does not need adenosine and has been shown to be non-inferior to FFR.
Recently, new physiological methods to assess ischemia have been developed and QFR was introduced as an angiography-derived physiology guidance. QFR does not require additional interrogation with a pressure wire, therefore, QFR assessment is more easily applicable in terms of cost, time, and safety and is more patient friendly with less discomfort related to hyperaemic state.
This study aims to demonstrate a non-inferiority of QFR-guidance PCI to usual care PCI, usual care PCI will be performed based on daily clinical practice, so this trial will aim to show whether QFR can replace wire-based iFR /FFR and improve clinical outcomes in daily practice when compared with the usual care.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
21/YH/0302
Date of REC Opinion
8 Apr 2022
REC opinion
Further Information Favourable Opinion