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
NCT ID: NCT04923191
Last Updated: 2023-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
2540 participants
INTERVENTIONAL
2021-11-12
2029-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PIONIR Study (Presillion™ and Presillion™ Plus Stent Systems)
NCT00840775
Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population
NCT01556126
Post-Market Registry to Evaluate the Safety and Efficacy of the The SUPRAFLEX CRUZ™ Sirolimus Eluting Coronary Stent System in the Treatment of an Octo- and Nonagenerian All-Comer Patient Cohort With Coronary Artery Disease - the Cruz Senior Study
NCT04612179
Randomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent
NCT02328898
Safety and Efficacy Study of CYPHER® Sirolimus Stent and ENDEAVOR® Zotarolimus Stent in Patients With Acute ST Elevation Myocardial Infarction (STEMI) and Analysis of Current Status of Emergency PCI Green Channel for STEMI Patients in China
NCT00781716
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Angiography-derived Physiology Guidance: angio-FFR (QFR and caFFR)
Quantitative Flow Ratio- QFR, Coronary angiography-derived FFR - caFFR
Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care
percutaneous coronary intervention
Local routine diagnostic procedure (LRDP) and usual care
Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care
percutaneous coronary intervention
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care
percutaneous coronary intervention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National University of Ireland, Galway, Ireland
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Patrick Serruys
Professor of Interventional Cardiology & Innovation at the National University of Ireland, Galway, Ireland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Faisal Sharif, MD
Role: primary
Andreas Baumbach, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
He X, Tsung-Ying T, Revaiah PC, Wykrzykowska JJ, Rosseel L, Sharif F, Muramatsu T, Reiber JH, Garg S, Miyashita K, Tobe A, Tao L, Onuma Y, Serruys PW. Nomogram based on virtual hyperemic pullback pressure gradients for predicting the suboptimal post-PCI QFR outcome after stent implantation. Int J Cardiovasc Imaging. 2024 Dec;40(12):2469-2479. doi: 10.1007/s10554-024-03253-1. Epub 2024 Oct 12.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NUIG-2021-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.