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Completed

NCT Number: NCT04475536

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

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

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Key information

Conditions

Ischemic Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela, LA Coruña, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TANSEI stent

Device

stenting with the TANSEI sirolimus-eluting stent

Primary outcomes

  1. 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).

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

    Time frame: 12 months

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

Secondary outcomes

  1. All death.

    Time frame: 12 months

    All death.

  2. Cardiac death.

    Time frame: 12 months

    Cardiac death.

  3. Target Vessel revascularization.

    Time frame: 12 months

    Target Vessel revascularization.

  4. Target lesion revascularization.

    Time frame: 12 months

    Target lesion revascularization.

  5. Stent thrombosis (ARC definite/probable).

    Time frame: 12 months

    Stent thrombosis (ARC definite/probable).

  6. Major bleeding event (BARC type 2-5).

    Time frame: 12 months

    Major bleeding event (BARC type 2-5).

  7. Stroke.

    Time frame: 12 months

    Stroke.

  8. Procedural success.

    Time frame: 12 months

    Procedural success ( Residual stenosis <30% after implantation at the narrowest point of the treated vascular segment).

  9. Rate of patients with DAPT

    Time frame: From 1 to 6 months

    Rate of patients with DAPT

  10. Rate of patients with DAPT

    Time frame: From 6 to 12 months

    Rate of patients with DAPT

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Acronym: TANSEI

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jul 17, 2020
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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