NCT06420505招募中不适用
Multicenter Observatory Evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System VIVO ISAR in Routine Clinical Practice (CELEBRITY Observatory)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 19
- 主要终点
- rate of target lesion failure
研究概览
简要总结
The rationale for this observatory is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent System in Real World CAD Patients with follow-up at 12 months. All medications and procedures to be used/ performed in this observatory are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.
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
- •≥18 years old
- •Ability to provide signed informed consent form.
- •Male or non-pregnant female patient (Pregnancy status to be confirmed verbally from the female patient of reproductive age)
- •Presentation with acute coronary syndrome or chronic coronary syndrome with stable angina or angina equivalent symptoms or with a positive noninvasive test for ischemia or evidence of a functionally significant coronary stenosis.
- •Patient having social security number.
- •Patient treated only with Vivo ISAR stent in case of single or multiple vessel stenting
排除标准
- •Concurrent participation in another clinical trial.
- •Having benefited from an angioplasty of ≤ 1 month with a stent other than Vivo ISAR.
- •Planned elective surgery in next 6 months
- •Cardiogenic shock/ hemodynamically unstable patients
- •Concurrent medical condition with a life expectancy of less than 12 months
- •History of cerebrovascular accident in the last 6 months.
- •Vulnerable patient under guardianship or curatorship
结局指标
主要结局
rate of target lesion failure
时间窗: 12 months post-procedure
• The rate of target lesion failure at 12 months follow-up defined as the composite endpoint of: * Cardiac death * Myocardial infarction related to the target vessel * Clinically documented target lesion revascularization
次要结局
- Device success rate(12 months post-procedure)
- Procedural success rate(7 days post-procedure)
- • Evaluate the antiplatelet treatment(12 months post-procedure)
- Assess reperfusion(12 months post-procedure)
研究者
研究点 (19)
Loading locations...
相似试验
进行中（未招募）
不适用
Plasmafit® Revision Structan® Hip Endoprosthesis CupOsteolysisArthroplasty ComplicationsInstability of Prosthetic JointDegenerative OsteoarthritisFractures, HipFemoral Head Avascular NecrosisProsthesis FailureRheumatic ArthritisNCT04255966Aesculap AG60
进行中（未招募）
不适用
An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate CancerProstate CancerNCT05712473Lantheus Medical Imaging500
已完成
不适用
Study to Evaluate Made-to-measure Compression GarmentsLymphedemaNCT04901962BSN Medical GmbH99
撤回
不适用
Observational Patient Registry of the Dynamic Locking ScrewsProximal or Diaphyseal Humerus FractureDiaphyseal or Distal Femur FractureDiaphyseal, Distal or Proximal Tibia FractureNCT02656628Synthes GmbH
招募中
不适用
Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing SystemNCT06775704Medacta International SA150