Coronary Artery Disease, Ischemic Heart Disease
Conditions
Keywords
Complex Lesions
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 .
Interventions
DEVICETANSEI stent
stenting with the TANSEI sirolimus-eluting stent
Sponsors
Fundación EPIC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Efficacy.The incidence of clinically driven target lesion revascularization. | 12 months | The incidence of clinically driven target lesion revascularization (TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel revascularization. | 12 months | Target Vessel revascularization. |
| Target lesion revascularization. | 12 months | Target lesion revascularization. |
| Stent thrombosis (ARC definite/probable). | 12 months | Stent thrombosis (ARC definite/probable). |
| All death. | 12 months | All death. |
| Stroke. | 12 months | Stroke. |
| Procedural success. | 12 months | Procedural success ( Residual stenosis \<30% after implantation at the narrowest point of the treated vascular segment). |
| Rate of patients with DAPT | From 1 to 6 months | Rate of patients with DAPT |
| Major bleeding event (BARC type 2-5). | 12 months | Major bleeding event (BARC type 2-5). |
| Cardiac death. | 12 months | Cardiac death. |
Countries
Spain
Outcome results
None listed