NCT00850213已完成不适用
Registro Redes - Evaluación Del Comportamiento clínico y Del Coste Del Stent Coronario Endeavor Resolute de Medtronic "en el Mundo Real" en España
Medtronic Bakken Research Center6 个研究点 分布在 1 个国家目标入组 448 人开始时间: 2009年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 448
- 试验地点
- 6
- 主要终点
- Overall patient cost
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Overall patient cost
时间窗: During initial hospitalization and at 12 month follow-up
Number of major adverse cardiac events (MACE)
时间窗: 30 days, 6 months and 1 year
次要结局
- Procedure, device and lesion success rate(30 Days)
- Rate of stent thrombosis (according to ARC criteria, defined as definite/confirmed, probable and possible)(12 Months)
- Target Lesion Revascularization (TLR)(12 Months)
研究者
研究点 (6)
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