Status:
COMPLETED
A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.
Lead Sponsor:
Fundación EPIC
Conditions:
Ischemic Heart Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.
Detailed Description
This prospective registry is intended to analyze clinical outcomes in patients treated with TANSEI stent in patients with complex coronary lesions .
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT04475536
Start Date
August 21 2020
End Date
February 1 2024
Last Update
February 26 2025
Active Locations (17)
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1
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, LA Coruña, Spain, 15706
2
Hospital Universitario de A Coruña
A Coruña, Spain, 15006
3
Hospital General Universitario
Albacete, Spain, 02006
4
Hospital Del Mar
Barcelona, Spain, 08003