RecruitingNot Applicable

The PIONEER-IV Study is Comparing Clinical Outcomes Between Angiography-derived Physiology Guidance to Usual Care in an All-comers PCI Population With Unrestrictive Use of the HT Supreme Sirolimus-eluting Stent

Belgium2,540 participantsStarted 2021-11-12

Plain-language summary

PIONEER-IV is a prospective, single-blind (patient), randomized, 1:1, controlled, multi-center study comparing clinical outcomes between angiography-derived physiology guidance to 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. Patients will be randomized to either angio-based physiology guidance angio-FFR (Quantitative Flow Ratio and coronary angiography-derived FFR, caFFR) or local routine diagnostic procedure (LRDP) and usual care. Patients will be treated with 1-year P2Y12 inhibitor monotherapy after 1-month of dual-antiplatelet therapy in approximately 2540 (2\*1270) patients. All patients (both cohorts) must receive dual anti-platelet therapy, being aspirin (ASA) and ticagrelor for 1 month, followed by 11 months of ticagrelor only (i.e. monotherapy). At 1 year, ticagrelor monotherapy is replaced by aspirin monotherapy or left to the discretion of the operator.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice);
✕. Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors;
✕. Planned major elective surgery requiring discontinuation of (dual)anti platelet therapy (DAPT) within 12 months of procedure;
✕. Concurrent medical condition with a life expectancy of less than 3 years;
✕. Currently participating in another trial and not yet at its primary endpoint;
✕. Active pathological bleeding;
✕. History of intracranial haemorrhage.

What they're measuring

Patient-oriented Composite Endpoint (PoCE)

Timeframe: 12 months

Trial details

NCT IDNCT04923191

SponsorNational University of Ireland, Galway, Ireland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01

Contact for this trial

Patrick W Serruys, MD

+31622924061 Patrick.Serruys@universityofgalway.ie

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