Assessment of Clinical Performance and Costs of the Endeavor Resolute Stent in Real Life in Spain.

Study Overview
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Brief Summary
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The Redes registry is set up to document the overall clinical performance and costs of the Endeavor Resolute coronary stent in a real life subject population of 450 patients that require a stent in Spain. Primary objectives are the overall cost for patients during initial hospitalization and at 1-year follow-up, as well as the MACE rate at 30 days, 6 months and 12 months post procedure.

Official Title
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Registro Redes - Evaluación Del Comportamiento clínico y Del Coste Del Stent Coronario Endeavor Resolute de Medtronic en el Mundo Real en España

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Endeavor Resolute Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is >18 years old Subject has agreed to participate in the study by signing the Patient Informed Consent and/or has authorized the collection and disclosure of their personal health information by signing the Patient Data Collection Form. There is an indication for a drug-eluting stent and a clinical decision to use Endeavor Resolute in all the lesions found. Subject is able and willing to co-operate and to comply with the study protocol and undergo follow-up requirements. Exclusion Criteria: Subject is a childbearing or breastfeeding female. Subject has a known hypersensitivity or allergy to acetylsalicylic acid, heparin, clopidogrel, ticlopidine, drugs such as zotarolimus, rapamycin, tacrolimus, sirolimus or other similar drugs, or any other analog or derivative drug, cobalt, chrome, nickel, molybdenum or contrast media. Subject has a contraindication to anticoagulants and/or antiplatelets. Subject's lesion might prevent proper balloon inflation during angioplasty. Primary or rescue angioplasty. Subject has one or more drug-eluting stents other than Endeavor Resolute in other lesions. Intention for elective treatment with other drug-eluting stent other than Endeavor Resolute. Current medical condition is associated with a life expectancy ≤ 12 months. Subject is participating in another investigational drug or device study and has not completed the follow-up required for that study at least 30 days prior to signing the consent form in this study. Subject can only be enrolled once in this study. Subject has a medical condition preventing follow-up as established in the protocol or limiting participation in this study. Subject cannot guarantee follow-up.

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 |
| --- | --- |
| Endeavor Resolute Stent<br>Patients implanted with the Medtronic Endeavor Resolute stent | Device: Endeavor Resolute Stent<br>* Single implantation<br>* Other names: Medtronic Endeavor Resolute Coronary Stent System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall patient cost |  | During initial hospitalization and at 12 month follow-up | 
| Number of major adverse cardiac events (MACE) |  | 30 days, 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of stent thrombosis (according to ARC criteria, defined as definite/confirmed, probable and possible) |  | 12 Months | 
| Target Lesion Revascularization (TLR) |  | 12 Months | 
| Procedure, device and lesion success rate |  | 30 Days |