A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.

Coronary Artery Disease Clinical Trial

— TANSEI  

Official title:

A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04475536
• Other study ID #: EPIC08-TANSEI
• Status: Active, not recruiting
• Start date: August 21, 2020
• Est. completion date: February 1, 2024

Study information

• Verified date: April 2023
• Source: Fundación EPIC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.

Description:

This prospective registry is intended to analyze clinical outcomes in patients treated with TANSEI stent in patients with complex coronary lesions .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 501
• Est. completion date: February 1, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age> 18 years.
• 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:

• Cardiogenic shock at the time of the PCI(Percutaneous Coronary Intervention).
• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• TANSEI stent
stenting with the TANSEI sirolimus-eluting stent

Locations

Country	Name	City	State
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 A Coruña	Coruña
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 Santiago de Compostela	Santiago De Compostela	LA Coruña
Spain	Hospital Clinico Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).	The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).	12 months
Primary	Efficacy.The incidence of clinically driven target lesion revascularization.	The incidence of clinically driven target lesion revascularization (TLR).	12 months
Secondary	All death.	All death.	12 months
Secondary	Cardiac death.	Cardiac death.	12 months
Secondary	Target Vessel revascularization.	Target Vessel revascularization.	12 months
Secondary	Target lesion revascularization.	Target lesion revascularization.	12 months
Secondary	Stent thrombosis (ARC definite/probable).	Stent thrombosis (ARC definite/probable).	12 months
Secondary	Major bleeding event (BARC type 2-5).	Major bleeding event (BARC type 2-5).	12 months
Secondary	Stroke.	Stroke.	12 months
Secondary	Procedural success.	Procedural success ( Residual stenosis <30% after implantation at the narrowest point of the treated vascular segment).	12 months
Secondary	Rate of patients with DAPT	Rate of patients with DAPT	From 1 to 6 months
Secondary	Rate of patients with DAPT	Rate of patients with DAPT	From 6 to 12 months