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

NCT04475536 | Completed DMC

• 1 other identifier: EPIC08-TANSEI
• Study Type: observational
• Target: 501
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Ischemic Heart Disease; Coronary Artery Disease

Keywords

Complex Lesions

Outcome Measures

Primary Outcomes (2)

• 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

• Efficacy.The incidence of clinically driven target lesion revascularization.

  The incidence of clinically driven target lesion revascularization (TLR).

  12 months

Secondary Outcomes (10)

• All death.

  12 months

• Cardiac death.

  12 months

• Target Vessel revascularization.

  12 months

• Target lesion revascularization.

  12 months

• Stent thrombosis (ARC definite/probable).

  12 months

Study Arms (1)

Coronary Artery Disease (CAD)

Device: TANSEI stent

Interventions

TANSEI stent DEVICE

stenting with the TANSEI sirolimus-eluting stent

Coronary Artery Disease (CAD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with de novo native and complex coronary artery lesions, candidate to undergo revascularisation with a coronary device.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (17)

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, LA Coruña, 15706, Spain

Location

Hospital Universitario de A Coruña

A Coruña, 15006, Spain

Location

Hospital General Universitario

Albacete, 02006, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital General Universitario de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario de Cabueñes

Gijón, 33394, Spain

Location

Hospital General Juan Ramon Jimenez

Huelva, 21005, Spain

Location

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, 35010, Spain

Location

Hospital Universitario de León

León, 24001, Spain

Location

Hospital Universitario Lucus Agusti

Lugo, 27003, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, 28222, Spain

Location

Hospital Universitario Virgen de La Victoria

Málaga, 29010, Spain

Location

Hospital Clinico Universitario Virgen Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Marques de Valdcilla

Santander, 39008, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (5)

• 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.

  PMID: 24847155 BACKGROUND

• 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.

  PMID: 26268482 BACKGROUND

• 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.

  PMID: 26864951 BACKGROUND

• 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.

  PMID: 28485275 BACKGROUND

• 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.

  PMID: 29246909 BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 17, 2020
• Study Start: August 21, 2020
• Primary Completion: May 1, 2023
• Study Completion: February 1, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

ES (17)