A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.
NCT ID: NCT04475536
Last Updated: 2025-02-26
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
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COMPLETED
501 participants
OBSERVATIONAL
2020-08-21
2024-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Coronary Artery Disease (CAD)
TANSEI stent
stenting with the TANSEI sirolimus-eluting stent
Interventions
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TANSEI stent
stenting with the TANSEI sirolimus-eluting stent
Eligibility Criteria
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Inclusion Criteria
* With indication of percutaneous revascularization.
* Complex coronary lesion defined as:
* Left main lesion AND/OR
* Lesion located at a major bifurcation (side branch \>2mm) AND/OR
* Lesion located in a small vessel (\<2.5 mm reference diameter by visual estimation) AND/OR
* Lesion length \> 35 mm
* Informed consent signed.
Exclusion Criteria
* Life expectancy of the patient under 1 year.
* Patients included in other studies or clinical trials.
* Clinical decision that excludes the use of drug-eluting stents.
* Confirmed allergy to aspirin and / or thienopyridines.
18 Years
ALL
No
Sponsors
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Fundación EPIC
OTHER
Responsible Party
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Locations
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Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, LA Coruña, Spain
Hospital Universitario de A Coruña
A Coruña, , Spain
Hospital General Universitario
Albacete, , Spain
Hospital Del Mar
Barcelona, , Spain
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario de Cabueñes
Gijón, , Spain
Hospital General Juan Ramon Jimenez
Huelva, , Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Universitario de León
León, , Spain
Hospital Universitario Lucus Agusti
Lugo, , Spain
Hospital Universitario Puerta de Hierro
Majadahonda, , Spain
Hospital Universitario Virgen de La Victoria
Málaga, , Spain
Hospital Clinico Universitario Virgen Arrixaca
Murcia, , Spain
Hospital Universitario Marques de Valdcilla
Santander, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Countries
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References
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Saito S, Valdes-Chavarri M, Richardt G, Moreno R, Iniguez Romo A, Barbato E, Carrie D, Ando K, Merkely B, Kornowski R, Eltchaninoff H, James S, Wijns W; CENTURY II Investigators. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial. Eur Heart J. 2014 Aug 7;35(30):2021-31. doi: 10.1093/eurheartj/ehu210. Epub 2014 May 19.
Orvin K, Carrie D, Richardt G, Desmet W, Assali A, Werner G, Ikari Y, Fujii K, Goicolea J, Dangoisse V, Manari A, Saito S, Wijns W, Kornowski R. Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial. Catheter Cardiovasc Interv. 2016 May;87(6):1092-100. doi: 10.1002/ccd.26150. Epub 2015 Aug 13.
Lesiak M, Araszkiewicz A, Grajek S, Colombo A, Lalmand J, Carstensen S, Namiki A, Tobaru T, Merkely B, Moreno R, Barbato E, Wijns W, Saito S. Long Coronary Lesions Treated With Thin Strut Bioresorbable Polymer Drug Eluting Stent: Experience From Multicentre Randomized CENTURY II Study. J Interv Cardiol. 2016 Feb;29(1):47-56. doi: 10.1111/joic.12262.
Derimay F, Souteyrand G, Motreff P, Rioufol G, Finet G. Influence of platform design of six different drug-eluting stents in provisional coronary bifurcation stenting by rePOT sequence: a comparative bench analysis. EuroIntervention. 2017 Oct 13;13(9):e1092-e1095. doi: 10.4244/EIJ-D-16-00863.
Chevalier B, Smits PC, Carrie D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamie D, Kraaijeveld AO, Hovasse T, Vlachojannis GJ. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months). Circ Cardiovasc Interv. 2017 Dec;10(12):e004801. doi: 10.1161/CIRCINTERVENTIONS.116.004801.
Other Identifiers
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EPIC08-TANSEI
Identifier Type: -
Identifier Source: org_study_id
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