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

NCT04923191 · tracked via the Priya Life Science Ireland tracker

Sponsor

National University of Ireland, Galway, Ireland

Phase

Not applicable

Started

2021-11-12

Last updated

2023-10-30

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care

Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care: percutaneous coronary intervention

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: 1. 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); 2. Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors; 3. Planned major elective surgery requiring discontinuation of (dual)anti platelet therapy (DAPT) within 12 months of procedure; 4. Concurrent medical condition with a life expectancy of less than 3 years; 5. Currently participating in another trial and not yet at its primary endpoint; 6. Active pathological bleeding; 7. History of intracranial haemorrhage.

Primary outcome measure(s)

Patient-oriented Composite Endpoint (PoCE) — 12 months
PoCE is a composite clinical endpoint of: * all-cause death; * any stroke, Modified Rankin scale, (MRS ≥1); * any myocardial infarction; * any clinically and physiologically driven revascularization.

Trial sites (19)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04923191 on ClinicalTrials.gov ↗ ← All trials in Ireland