Clinical trial NCT04923191: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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)
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 2540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Patient-oriented Composite Endpoint (PoCE)
timeFrame: 12 months
Secondary outcomes:
measure: Vessel-oriented composite endpoints (VoCE)
timeFrame: 12, 24 and 36 months
measure: Device-oriented composite endpoint (DoCE)
timeFrame: 12, 24 and 36 months
measure: Myocardial Infarction (MI)
timeFrame: 48 hours post-procedure
measure: Device Success Rate
timeFrame: index procedure
measure: Stent Thrombosis
timeFrame: Procedure, 12, 24 and 36 months
measure: Target Vessel Failure (TVF)
timeFrame: 12, 24 and 36 months
measure: Bleeding
timeFrame: 12, 24 and 36 months follow-up
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Aalst
country: Belgium
facility: OLVZ Aalst
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Charleroi
country: Belgium
facility: CHU Charleroi
city: Hasselt
country: Belgium
facility: Jessa Hospital Hasselt
city: Galway
country: Ireland
facility: University Hospital Galway
city: Amsterdam
country: Netherlands
facility: OLVG Amsterdam
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente, Thoraxcentrum, Endchede
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Hague
country: Netherlands
facility: Den Haag Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Barcelona
country: Spain
facility: Hospital Clínico de Barcelona
city: Lugo
country: Spain
facility: Lucas Augusti Hospital
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario of Valladolid
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro Vigo
city: London
country: United Kingdom
facility: Barts Health NHS Trust, London
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Southampton
country: United Kingdom
facility: University Hospitals Southampton
Study officials:
References:
citation: 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.