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

February 25, 2025 updated by: Fundación EPIC
This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Albacete, Spain, 02006
        • Hospital General Universitario
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Ciudad Real, Spain, 13005
        • Hospital General Universitario de Ciudad Real
      • Coruña, Spain, 15006
        • Hospital Universitario de A Coruña
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Gijón, Spain, 33394
        • Hospital Universitario de Cabueñes
      • Huelva, Spain, 21005
        • Hospital General Juan Ramon Jimenez
      • Las Palmas De Gran Canaria, Spain, 35010
        • Hospital Universitario de Gran Canaria Dr. Negrin
      • León, Spain, 24001
        • Hospital Universitario de Leon
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Agustí
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta de Hierro
      • Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen Arrixaca
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdcilla
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
    • LA Coruña
      • Santiago De Compostela, LA Coruña, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Coronary Artery Disease (CAD)
Device: TANSEI stent
stenting with the TANSEI sirolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
Time Frame: 12 months
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.
Time Frame: 12 months
The incidence of clinically driven target lesion revascularization (TLR).
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All death.
Time Frame: 12 months
All death.
12 months
Cardiac death.
Time Frame: 12 months
Cardiac death.
12 months
Target Vessel revascularization.
Time Frame: 12 months
Target Vessel revascularization.
12 months
Target lesion revascularization.
Time Frame: 12 months
Target lesion revascularization.
12 months
Stent thrombosis (ARC definite/probable).
Time Frame: 12 months
Stent thrombosis (ARC definite/probable).
12 months
Major bleeding event (BARC type 2-5).
Time Frame: 12 months
Major bleeding event (BARC type 2-5).
12 months
Stroke.
Time Frame: 12 months
Stroke.
12 months
Procedural success.
Time Frame: 12 months
Procedural success ( Residual stenosis <30% after implantation at the narrowest point of the treated vascular segment).
12 months
Rate of patients with DAPT
Time Frame: From 1 to 6 months
Rate of patients with DAPT
From 1 to 6 months
Rate of patients with DAPT
Time Frame: From 6 to 12 months
Rate of patients with DAPT
From 6 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPIC08-TANSEI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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