Actively Recruiting
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
Led by National University of Ireland, Galway, Ireland · Updated on 2023-10-30
2540
Participants Needed
19
Research Sites
372 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has chronic stable angina, acute coronary syndromes or silent ischemia
- Presence of one or more coronary artery stenoses of 650% (by visual assessment) in a native coronary artery or in a suitable bypass conduit
- Vessel has reference diameter of at least 2.25 mm by visual assessment
- Patient has been informed about the study and provided written consent
You will not qualify if you...
- Woman who is pregnant or nursing (pregnancy test required within 7 days before procedure for women of child-bearing potential)
- Known intolerance to cobalt chromium or medications such as sirolimus, aspirin, heparin, bivalirudin, or P2Y12 inhibitors
- Planned major elective surgery requiring stopping dual antiplatelet therapy within 12 months
- Medical condition with life expectancy less than 3 years
- Currently participating in another trial and not yet at its primary endpoint
- Active pathological bleeding
- History of intracranial hemorrhage
AI-Screening
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Trial Site Locations
Total: 19 locations
1
ASZ Aalst
Aalst, Belgium
Actively Recruiting
2
OLVZ Aalst
Aalst, Belgium
Actively Recruiting
3
Imelda Ziekenhuis
Bonheiden, Belgium
Actively Recruiting
4
CHU Charleroi
Charleroi, Belgium
Actively Recruiting
5
Jessa Hospital Hasselt
Hasselt, Belgium
Actively Recruiting
6
University Hospital Galway
Galway, Ireland
Actively Recruiting
7
OLVG Amsterdam
Amsterdam, Netherlands
Actively Recruiting
8
Medisch Spectrum Twente, Thoraxcentrum, Endchede
Enschede, Netherlands
Actively Recruiting
9
UMC Groningen
Groningen, Netherlands
Actively Recruiting
10
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Actively Recruiting
11
Maasstad Ziekenhuis
Rotterdam, Netherlands
Actively Recruiting
12
Den Haag Ziekenhuis
The Hague, Netherlands
Actively Recruiting
13
Hospital Clínico de Barcelona
Barcelona, Spain
Actively Recruiting
14
Lucas Augusti Hospital
Lugo, Spain
Actively Recruiting
15
Hospital Clínico Universitario of Valladolid
Valladolid, Spain
Actively Recruiting
16
Hospital Álvaro Cunqueiro Vigo
Vigo, Spain
Actively Recruiting
17
Barts Health NHS Trust, London
London, United Kingdom
Actively Recruiting
18
Freeman Hospital
Newcastle, United Kingdom
Actively Recruiting
19
University Hospitals Southampton
Southampton, United Kingdom
Actively Recruiting
Research Team
P
Patrick W Serruys, MD
CONTACT
Y
Yoshinobu Onuma, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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