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 | Recruiting DMC

• 1 other identifier: NUIG-2021-001
• Study Type: interventional
• Target: 2,540
• Locations: 5 countries
• Sites: 19

Brief 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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; ischemia; quantitative flow ratio (QFR); P2Y12 monotherapy; drug-eluting stent; physiology guidance; angio-FFR; Coronary Angiography-derived FFR (caFFR)

Outcome Measures

Primary Outcomes (1)

• Patient-oriented Composite Endpoint (PoCE)

  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.

  12 months

Secondary Outcomes (7)

• Vessel-oriented composite endpoints (VoCE)

  12, 24 and 36 months

• Device-oriented composite endpoint (DoCE)

  12, 24 and 36 months

• Myocardial Infarction (MI)

  48 hours post-procedure

• Device Success Rate

  index procedure

• Stent Thrombosis

  Procedure, 12, 24 and 36 months

Study Arms (2)

Angiography-derived Physiology Guidance: angio-FFR (QFR and caFFR)

OTHER

Quantitative Flow Ratio- QFR, Coronary angiography-derived FFR - caFFR

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

Local routine diagnostic procedure (LRDP) and usual care

OTHER

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

Interventions

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

percutaneous coronary intervention

Angiography-derived Physiology Guidance: angio-FFR (QFR and caFFR); Local routine diagnostic procedure (LRDP) and usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead

Study Sites (19)

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

Related Publications (2)

• He X, Tsung-Ying T, Revaiah PC, Wykrzykowska JJ, Rosseel L, Sharif F, Muramatsu T, Reiber JH, Garg S, Miyashita K, Tobe A, Tao L, Onuma Y, Serruys PW. Nomogram based on virtual hyperemic pullback pressure gradients for predicting the suboptimal post-PCI QFR outcome after stent implantation. Int J Cardiovasc Imaging. 2024 Dec;40(12):2469-2479. doi: 10.1007/s10554-024-03253-1. Epub 2024 Oct 12.

  PMID: 39395074 DERIVED

• Hara H, Serruys PW, O'Leary N, Gao C, Murray A, Breslin E, Garg S, Bureau C, Reiber JH, Barbato E, Aminian A, Janssens L, Rosseel L, Benit E, Campo G, Guiducci V, Casella G, Santarelli A, Franze A, Diaz VAJ, Iniguez A, Brugaletta S, Sabate M, Amat-Santos IJ, Amoroso G, Wykrzykowska J, von Birgelen C, Somi S, Liu T, Hofma SH, Curzen N, Trillo R, Ocaranza R, Mathur A, Smits PC, Escaned J, Baumbach A, Wijns W, Sharif F, Onuma Y; PIONEER IV trial investigator. Angiography-derived physiology guidance vs usual care in an All-comers PCI population treated with the healing-targeted supreme stent and Ticagrelor monotherapy: PIONEER IV trial design. Am Heart J. 2022 Apr;246:32-43. doi: 10.1016/j.ahj.2021.12.018. Epub 2022 Jan 3.

  PMID: 34990582 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Patrick W Serruys, MD

CONTACT

+31622924061; Patrick.Serruys@universityofgalway.ie

Yoshinobu Onuma, MD

CONTACT

+353852882318; Yoshinobu.Onuma@universityofgalway.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Interventional Cardiology & Innovation at the National University of Ireland, Galway, Ireland

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 11, 2021
• Study Start: November 12, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

GB (3); IE (1); BE (5); NL (6); ES (4)