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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form as approved by the Ethical Committee and is willing to comply with all protocol-required (follow-up) evaluations. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

OTHER

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

percutaneous coronary intervention

Locations (19)

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