A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.
- Conditions
- Coronary Artery DiseaseIschemic Heart Disease
- Interventions
- Device: TANSEI stent
- Registration Number
- NCT04475536
- Lead Sponsor
- Fundación EPIC
- 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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 501
-
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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Coronary Artery Disease (CAD) TANSEI stent -
- Primary Outcome Measures
Name Time Method Efficacy.The incidence of clinically driven target lesion revascularization. 12 months The incidence of clinically driven target lesion revascularization (TLR).
Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). 12 months The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
- Secondary Outcome Measures
Name Time Method Target Vessel revascularization. 12 months Target Vessel revascularization.
Cardiac death. 12 months Cardiac death.
All death. 12 months All death.
Target lesion revascularization. 12 months Target lesion revascularization.
Rate of patients with DAPT From 6 to 12 months Rate of patients with DAPT
Stent thrombosis (ARC definite/probable). 12 months Stent thrombosis (ARC definite/probable).
Major bleeding event (BARC type 2-5). 12 months Major bleeding event (BARC type 2-5).
Stroke. 12 months Stroke.
Procedural success. 12 months Procedural success ( Residual stenosis \<30% after implantation at the narrowest point of the treated vascular segment).
Trial Locations
- Locations (17)
Hospital Clinico Universitario de Santiago de Compostela
🇪🇸Santiago De Compostela, LA Coruña, Spain
Hospital Universitari Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital Del Mar
🇪🇸Barcelona, Spain
Hospital General Universitario
🇪🇸Albacete, Spain
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
Hospital Universitario de A Coruña
🇪🇸Coruña, Spain
Hospital General Universitario de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital Universitario de Cabueñes
🇪🇸Gijón, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital General Juan Ramon Jimenez
🇪🇸Huelva, Spain
Hospital Universitario de León
🇪🇸León, Spain
Hospital Universitario Lucus Agusti
🇪🇸Lugo, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Clinico Universitario Virgen Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario Virgen de La Victoria
🇪🇸Málaga, Spain
Hospital Universitario Marques de Valdcilla
🇪🇸Santander, Spain