The SUNRISE Registry - A Multicenter Post-Market Surveillance With the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)
研究概览
简要总结
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial aneurysms.
详细描述
The data will be collected in consecutive subjects treated with the commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CORDIS ENTERPRISE™ VRD during the index procedure. While only limited inclusion or exclusion criteria are specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up up to 6 months. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the VRD placement, coiling procedure, application of antiplatelet medication and any other medical therapy to be provided according to local usual practice.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be >= 18 years of age and less than 80 years.
- •Diagnosis of a ruptured (Hunt and Hess Grade I - III) or unruptured intracranial aneurysm at the time of the treatment
- •Subject (or his/her legal representative) provides written informed consent for the use of his/her peri-procedural and follow-up data
排除标准
- •Diagnosis of Hunt and Hess Grade IV or V subarachnoid hemorrhage at the time of the treatment
- •Severe co-morbidity associated with a life-expectancy of less than six months
- •Poor neurological status at baseline
- •Known allergies to Nitinol metal
- •Known allergies to aspirin, heparin, ticlopidine, or clopidogrel or unable or unwilling to tolerate therapy
- •Participation in an investigational drug or another device study is only allowed after written approval of the coordinating investigator or Cordis Medical Monitor.
- •Implantation of an intracranial stent associated with the symptomatic distribution within 12 weeks prior to the index procedure
- •Implantation of carotid stent associated with the symptomatic distribution within 12 weeks prior to the index procedure
- •Atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
结局指标
主要结局
The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)
时间窗: Intra-procedure
Successful intracranial VRD placement is defined as stable VRD placement with complete coverage of the aneurysm neck and parent artery patency. Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
次要结局
- Device or Procedure Related Adverse Events (AEs)(index procedure to discharge; an average of 3.8 days)
- Satisfactory Coil Mass Position(6 months)
- Aneurysm Occlusion(post procedure to 6 months)