BiOSS Study (BiOSS LIM C Stent Registry in Bifurcated Lesions)

Study Overview
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Brief Summary
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The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.

Detailed Description
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The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.

Official Title
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BiOSS LIM C Stent Registry in Bifurcated Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Coronary angioplasty with stent implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years. Clinical indication of coronary angioplasty in bifurcated lesion. Bifurcated lesions with both distal branches at least 2 mm in diameter. The lesion must be located in the main branch, with a severe stenosis by visual estimation at some point in the main branch, with or without involvement of the lateral branch. Express acceptance and signature of informed consent. Exclusion Criteria: Express rejection of the patient to participate in the study. Exclusive involvement of the lateral branch (Medina lesion 001). Contraindication for antiplatelet treatment. Lesions due to restenosis. Lesions in saphenous grafts. Total chronic occlusions. Cardiogenic shock.

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 |
| --- | --- |
| Patients with coronary artery disease<br>(coronary artery disease) | Procedure: Coronary angioplasty with stent implantation<br>* Coronary angioplasty with BiOSS LIM C stent implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful angioplasty | After angiography: TIMI (thrombolysis in myocardial infarction ) 3 (both branches). With respect to reference diameter, none of the segments treated with stent has a residual stenosis> 30% or> 50% in those not treated with stent. | 1 day | 
| MACE | Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR) | 30 days | 
| MACE | Cumulative rate of major adverse cardiovascular events (MACE) including cardiac | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel revascularization | Target vessel revascularization | 30 days | 
| Percentage of stent struts malposition | Percentage of stent struts malposition | 30 days | 
| contrast media volume | contrast media volume | 1 day | 
| Angioplasty time | Angioplasty time | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting stent, Dedicated bifurcation stent, Cobalt-chromium, Sirolimus-eluting stent