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

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT04923191

Run by

National University of Ireland, Galway, Ireland

People needed

2540

Starts

2021-11-12

Expected to finish

2029-01-01

Last updated by the study team

2023-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has chronic stable angina, acute coronary syndromes or silent ischemia;
• Presence of one or more coronary artery stenoses of ≥50% (by visual assessment) in a native coronary artery (with or without prior stent/other device treatment) or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation;
• The vessel should have a reference vessel diameter of at least 2.25 mm by visual assessment (no limitation on the number of treated lesions, vessels, or lesion length);
• Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required (follow-up) evaluations.

You may not qualify if…

• 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.

Where it is running

• ASZ Aalst — Aalst, Belgium (enrolling)
• OLVZ Aalst — Aalst, Belgium (enrolling)
• Imelda Ziekenhuis — Bonheiden, Belgium (enrolling)
• CHU Charleroi — Charleroi, Belgium (enrolling)
• Jessa Hospital Hasselt — Hasselt, Belgium (enrolling)
• University Hospital Galway — Galway, Ireland (enrolling)
• OLVG Amsterdam — Amsterdam, Netherlands (enrolling)
• Medisch Spectrum Twente, Thoraxcentrum, Endchede — Enschede, Netherlands (enrolling)
• UMC Groningen — Groningen, Netherlands (enrolling)
• Medisch Centrum Leeuwarden — Leeuwarden, Netherlands (enrolling)
• Maasstad Ziekenhuis — Rotterdam, Netherlands (enrolling)
• Den Haag Ziekenhuis — The Hague, Netherlands (enrolling)
• Hospital Clínico de Barcelona — Barcelona, Spain (enrolling)
• Lucas Augusti Hospital — Lugo, Spain (enrolling)
• Hospital Clínico Universitario of Valladolid — Valladolid, Spain (enrolling)
• Hospital Álvaro Cunqueiro Vigo — Vigo, Spain (enrolling)
• Barts Health NHS Trust, London — London, United Kingdom (enrolling)
• Freeman Hospital — Newcastle, United Kingdom (enrolling)
• University Hospitals Southampton — Southampton, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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