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

Study Overview
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Brief Summary
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This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.

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

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

Conditions
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Ischemic Heart Disease, Coronary Artery Disease

Intervention / Treatment
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* Device: TANSEI stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary Artery Disease (CAD)<br> | Device: TANSEI stent<br>* stenting with the TANSEI sirolimus-eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All death. | All death. | 12 months | 
| Cardiac death. | Cardiac death. | 12 months | 
| Target Vessel revascularization. | Target Vessel revascularization. | 12 months | 
| Target lesion revascularization. | Target lesion revascularization. | 12 months | 
| Stent thrombosis (ARC definite/probable). | Stent thrombosis (ARC definite/probable). | 12 months | 
| Major bleeding event (BARC type 2-5). | Major bleeding event (BARC type 2-5). | 12 months | 
| Stroke. | Stroke. | 12 months | 
| Procedural success. | Procedural success ( Residual stenosis <30% after implantation at the narrowest point of the treated vascular segment). | 12 months | 
| Rate of patients with DAPT | Rate of patients with DAPT | From 1 to 6 months | 
| Rate of patients with DAPT | Rate of patients with DAPT | From 6 to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complex Lesions