NCT03471234已完成不适用
LATIn American sTUdy to Investigate the Clinical Performance of Sirolimus-eluting Stent With Abluminal-only bioDEgradable Polymeric Coating (Inspiron TM) in the Treatment of Native Coronary Artery Lesions.
Scitech Produtos Medicos Ltda2 个研究点 分布在 1 个国家目标入组 299 人开始时间: 2018年9月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 299
- 试验地点
- 2
- 主要终点
- MACE (major cardiac events)
研究概览
简要总结
Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.
详细描述
Prospective, multicenter, single arm registry to assess the safety and performance of Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer for the treatment of "real world" patients.
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
- •All individuals aged over 18 years who signed the informed consent and had lesions in native coronary arteries treated only with Inspiron Sirolimus-Eluting stent.
排除标准
- •Saphenous vein grafts or Mammary lesions;
- •Individuals who have been treated within the last 6 months with another stent;
- •Acute myocardial infarction with ST segment elevation;
- •Chronic Total Occlusion
结局指标
主要结局
MACE (major cardiac events)
时间窗: 12 months
Major cardiac events (death, myocardial infarction, target vessel revascularization)
次要结局
- Acute success(up to 24 hours)
- Stent Thrombosis(24 months)
- MACE(24 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Post-market Clinical Study to Confirm Safety and Performance of PuraStat® for the Management of Bleeding in Vascular Surgery.Vascular Anastomosis SurgeryNCT031032823-D Matrix Europe SAS65
Unknown
不适用
Post-Market Clinical Study to Confirm Safety and Performance of PuraStat Absorbable Haemostatic Material for the Management of Bleeding in Liver SurgeryLiver ResectionNCT036001683-D Matrix Europe SAS80
招募中
不适用
Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center RegistryAcute Otitis MediaOtitis MediaOtitis Media With EffusionNCT05915078Smith & Nephew, Inc.200
终止
不适用
directSTIM™ Deep Brain Stimulation System Post-Market Clinical Follow-up Study on Essential TremorEssential TremorNCT05795218Aleva Neurotherapeutics SA21
已完成
不适用
A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select DevicesPediatric ProceduresAdult Hepato-pancreato-biliary (HPB) ProceduresAdult Lower Gastrointestinal ProceduresAdult Gastric ProceduresAdult Gynecological ProceduresAdult Urological ProceduresAdult Thoracic ProceduresNCT05039021Ethicon Endo-Surgery265