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
- Conditions
- Coronary Artery Disease
- Interventions
- Other: Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care
- Registration Number
- NCT04923191
- Lead Sponsor
- National University of Ireland, Galway, Ireland
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2540
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Local routine diagnostic procedure (LRDP) and usual care Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care - Angiography-derived Physiology Guidance: angio-FFR (QFR and caFFR) Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care Quantitative Flow Ratio- QFR, Coronary angiography-derived FFR - caFFR
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Vessel-oriented composite endpoints (VoCE) 12, 24 and 36 months VoCE is a composite clinical endpoint of:
* Vessel-related cardiovascular Death
* Target-vessel related MI
* Clinically and physiologically-oriented Target vessel revascularizationBleeding 12, 24 and 36 months follow-up Bleeding according to Bleeding Academic Research Consortium (BARC) (BARC 2, 3 and 5) classification
Device-oriented composite endpoint (DoCE) 12, 24 and 36 months DoCE is a composite endpoint of:
* Cardiovascular Death
* Target-vessel related MI
* Clinically and physiologically-oriented Target lesion revascularizationMyocardial Infarction (MI) 48 hours post-procedure Peri-procedure Myocardial Infarction according to 4th universal definition
Device Success Rate index procedure according to the statement from European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC)
Stent Thrombosis Procedure, 12, 24 and 36 months Definite, Probable, Definite or Probable
Target Vessel Failure (TVF) 12, 24 and 36 months TVF is a composite of:
* Cardiovascular Death
* Target-vessel related MI
* Clinically and physiologically-oriented Target vessel revascularization
Trial Locations
- Locations (19)
Hospital Clínico de Barcelona
🇪🇸Barcelona, Spain
University Hospitals Southampton
🇬🇧Southampton, United Kingdom
Hospital Clínico Universitario of Valladolid
🇪🇸Valladolid, Spain
ASZ Aalst
🇧🇪Aalst, Belgium
OLVZ Aalst
🇧🇪Aalst, Belgium
Medisch Spectrum Twente, Thoraxcentrum, Endchede
🇳🇱Enschede, Netherlands
Freeman Hospital
🇬🇧Newcastle, United Kingdom
Lucas Augusti Hospital
🇪🇸Lugo, Spain
Hospital Álvaro Cunqueiro Vigo
🇪🇸Vigo, Spain
University Hospital Galway
🇮🇪Galway, Ireland
Barts Health NHS Trust, London
🇬🇧London, United Kingdom
Den Haag Ziekenhuis
🇳🇱Hague, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Imelda Ziekenhuis
🇧🇪Bonheiden, Belgium
Jessa Hospital Hasselt
🇧🇪Hasselt, Belgium
CHU Charleroi
🇧🇪Charleroi, Belgium
OLVG Amsterdam
🇳🇱Amsterdam, Netherlands
UMC Groningen
🇳🇱Groningen, Netherlands
Maasstad Ziekenhuis
🇳🇱Rotterdam, Netherlands