Evaluation of the Safety and Efficacy of Titanium-nitric Oxide-coated Stent (Optimax®) in Patients With Lesions With a Low Risk of Restenosis (Diameter ≥ 3.0 mm and Length ≤ 20 mm)

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 Optimax® stent.

Detailed Description
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This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent in de novo coronary lesions with reference diameter ≥ 3.0 mm and Length ≤ 20 mm.

Official Title
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Prospective, Multicenter and Observational Registry for the Evaluation of the Safety and Efficacy of Titanium-nitric Oxide-coated Stent (Optimax®) in Patients With Lesions With a Low Risk of Restenosis (Diameter ≥ 3.0 mm and Length ≤ 20 mm) (Reto 320 Study)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Optimax stent®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with age ≥ 18 years old. Patients with de novo coronary lesion treated with Optimax® stent, reference diameter = 3.0 mm and length ≤ 20 mm. Informed consent signed. Exclusion Criteria: Refusal of the patient to participate at the study. Treatment of other injuries that do not meet the conditions (3x20).

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<br> | Device: Optimax stent®<br>* Percutaneous coronary intervention with Optimax stent®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety. The number of composite events of cardiac. | The number of composite events of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). | 6 and 12 month | 
| Efficacy: Incidence of clinically driven target lesion revascularization (TLR). | Incidence of clinically driven target lesion revascularization (TLR).Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | 6 and 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All death. | Systemic embolism, Major bleeding event (BARC ≥ 2). | 6 and 12 month | 
| Cardiac death. | Cardiac death. | 6 and 12 month | 
| Target Vessel revascularization. | Target Vessel revascularization. | 6 and 12 month | 
| Target lesion revascularization. | Target lesion revascularization. | 6 and 12 month | 
| Stent thrombosis (ARC definite/probable). | Stent thrombosis (ARC definite/probable). | 6 and 12 month | 
| Major bleeding event (BARC type 2-5). | Major bleeding event (BARC type 2-5). | 6 and 12 month | 
| Stroke. | Stroke. | 6 and 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cobalt-chromium