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.
ACTIVE_NOT_RECRUITING
NA
1550 participants
INTERVENTIONAL
2020-09-22
2026-09-30
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.
Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent
NCT00793221
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III)
NCT01078038
Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing
NCT00698607
Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent
NCT02870140
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
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
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SUPRAFLEX Cruz
Percutaneous Coronary Intervention with the SUPRAFLEX Cruz Sirolimus Eluting Bioabsorbable Polymer Coronary Stent System. It is a balloon expandable sirolimus eluting stent with an bioabsorbable polymer coating.
SUPRAFLEX Cruz
Percutaneous Coronary Intervention for multivessel disease
SYNERGY
Percutaneous Coronary Intervention with the SYNERGY EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with an bioabsorbable polymer coating.
SYNERGY
Percutaneous Coronary Intervention for multivessel disease
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SUPRAFLEX Cruz
Percutaneous Coronary Intervention for multivessel disease
SYNERGY
Percutaneous Coronary Intervention for multivessel disease
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. At least 1 stenosis (angiographic, visually determined de novo lesions with ≥50% DS) in all 3 major epicardial territories (LAD and/or side branch, LCX and/or side branch, RCA and/or side branch) supplying viable myocardium without left main involvement.
3. The vessel should have a reference vessel diameter ranging from ≥2.25 mm to ≤4.50 mm (no limitation on the number of treated lesions, vessels, or lesion length).
4. Patients with chronic coronary syndrome or stabilized acute coronary syndromes.
5. All anatomical SYNTAX Scores are eligible for initial screening with the SYNTAX Score II, provided that the SYNTAX Score II recommends equipoise risk (PCI or CABG) or PCI only.
6. 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 evaluations.
7. Agree with conditional longer follow up from 2 to 5 years with one phone contact yearly.
Exclusion Criteria
2. Unable to give informed consent.
3. 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).
4. Known contraindication to medications such as Aspirin, Heparin, Bivalirudin, Prasugrel and Ticagrelor.
5. Prior PCI or prior CABG.
6. Ongoing ST-elevation myocardial infarction (STEMI).
8. Concurrent medical condition with a life expectancy of less than 2 years.
9. Currently participating in another trial and not yet at its primary endpoint.
10. Patient with both ostial LAD and ostial LCX stenosis, or left main stenosis.
11. Previous 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
Established Professor of Interventional Medicine and Innovation, National University of Ireland, Galway (NUIG), Galway, Ireland
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrick W. Serruys, MD, PhD
Role: STUDY_CHAIR
National University of Ireland, Galway
William Wijns, MD, PhD
Role: STUDY_CHAIR
National University of Ireland, Galway
Yoshinobu Onuma, MD, PhD
Role: STUDY_CHAIR
National University of Ireland, Galway
Helge Moellmann, MD
Role: PRINCIPAL_INVESTIGATOR
St. Johannes Hospital
Manel Sabate, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínic of Barcelona
Azfar Zaman, MD
Role: PRINCIPAL_INVESTIGATOR
Freeman Hospital and Newcastle University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NUIG
Galway, , Ireland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kageyama S, Revaiah PC, Tsung-Ying T, Miyashita K, Tobe A, O'Leary N, Reiber JHC, Tu S, Zaman A, Sabate M, Mollmann H, Sharif F, Lemoine J, Wlodarczak A, Garg S, Onuma Y, Serruys PW. Diffuseness of coronary artery disease impacts on immediate hemodynamic and predicted clinical outcomes. Sci Rep. 2025 Jan 17;15(1):2228. doi: 10.1038/s41598-025-85872-9.
Ninomiya K, Serruys PW, Garg S, Hara H, Masuda S, Kageyama S, Kotoku N, Sevestre E, Kumar A, O'Kane P, Zaman A, Farah B, Magro M, Oemrawsingh RM, Mollmann H, Meneveau N, Achenbach S, Lemoine J, Allali A, Gallagher S, Wykrzykowska J, Lesiak M, Silvestri M, Wijns W, Sharif F, Onuma Y. The Utility of the SYNTAX Score II and SYNTAX Score 2020 for Identifying Patients with Three-Vessel Disease Eligible for Percutaneous Coronary Intervention in the Multivessel TALENT Trial: A Prospective Pilot Experience. Rev Cardiovasc Med. 2022 Apr 8;23(4):133. doi: 10.31083/j.rcm2304133. eCollection 2022 Apr.
Hara H, Gao C, Kogame N, Ono M, Kawashima H, Wang R, Morel MA, O'Leary N, Sharif F, Mollmann H, Reiber JHC, Sabate M, Zaman A, Wijns W, Onuma Y, Serruys PW. A randomised controlled trial of the sirolimus-eluting biodegradable polymer ultra-thin Supraflex stent versus the everolimus-eluting biodegradable polymer SYNERGY stent for three-vessel coronary artery disease: rationale and design of the Multivessel TALENT trial. EuroIntervention. 2020 Dec 18;16(12):e997-e1004. doi: 10.4244/EIJ-D-20-00772.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NUIG-2020-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.