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
Sponsor: National University of Ireland (NUI), Galway, Ireland
This is a prospective, single-blind (patient), randomized, 1:1, controlled, multi-center study comparing clinical outcomes between angiography-derived physiology guidance (Quantitative Flow Ratio, QFR) to local routine diagnostic procedure (LRDP) and usual care in an all-comers patient population (including patients with high bleeding risk, HBR) undergoing PCI with unrestrictive use of the HT Supreme sirolimus-eluting stent and treated with 1-year P2Y12 inhibitor monotherapy after 1-month of dual-antiplatelet therapy in approximately 2540 (2*1270) patient. The primary objective of this study is to compare QFR to LRDP and usual care in candidates for PCI with unrestricted use of the HT Supreme sirolimus-eluting stent, (non-inferiority).
Study Team:
Name sub-investigator: C. Lenselink
Name sub-investigator: J. Tiebesl
Project Manager: G.H. de Jong
Research Nurse: S.R. Stuiver