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

Coronary Artery Disease Clinical Trial

— PIONEER-IV  

Official title:

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 Supreme) Drug-eluting Stent and P2Y12 Inhibitor Monotherapy After 1-month of Dual-antiplatelet Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04923191
• Other study ID #: NUIG-2021-001
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: January 2029

Study information

• Verified date: October 2023
• Source: National University of Ireland, Galway, Ireland
• Contact: Patrick W Serruys, MD
• Phone: +31622924061
• Email: Patrick.Serruys[@]universityofgalway.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2540
• Est. completion date: January 2029
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland

Countries where clinical trial is conducted

Belgium,  Ireland,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vessel-oriented composite endpoints (VoCE)	VoCE is a composite clinical endpoint of: Vessel-related cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization	12, 24 and 36 months
Secondary	Device-oriented composite endpoint (DoCE)	DoCE is a composite endpoint of: Cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target lesion revascularization	12, 24 and 36 months
Secondary	Myocardial Infarction (MI)	Peri-procedure Myocardial Infarction according to 4th universal definition	48 hours post-procedure
Secondary	Device Success Rate	according to the statement from European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC)	index procedure
Secondary	Stent Thrombosis	Definite, Probable, Definite or Probable	Procedure, 12, 24 and 36 months
Secondary	Target Vessel Failure (TVF)	TVF is a composite of: Cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization	12, 24 and 36 months
Secondary	Bleeding	Bleeding according to Bleeding Academic Research Consortium (BARC) (BARC 2, 3 and 5) classification	12, 24 and 36 months follow-up