Prospective, Single-arm, Multi-center, Observational Study to Further Confirm Safety and Efficacy of the Dual-layer Micromesh Roadsaver Stent for the Treatment of Carotid Artery Stenosis in Patients Eligible for Elective Stenting Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,967
- 试验地点
- 57
- 主要终点
- The rate of Major Adverse Events (MAE)
研究概览
简要总结
Approximately 2000 patients eligible for elective treatment with a Carotid Stent according to hospital routine practice in centers across Europe will be enrolled in the study. The maximum number of patients enrolled at each site will be not limited. Follow-ups are scheduled at discharge, 30 days, and 1 year, as per local practice. Each patient will have follow-up contacts via hospital visit and/or telephone.
详细描述
- Baseline Assessments
The patient will be assessed in accordance with the hospital standard of care for patients treated with carotid artery stenting procedure, which in general includes:
- Informed consent for data collection
- Demographics
- Medical History
- Medication record
- Physical examination
- Carotid Duplex Ultrasound
- Neurological Assessment
- Diffusion weighted Magnetic Resonance Imaging (DW-MRI)
- Procedural angiography
Baseline assessments will be performed prior to the index procedure and documented in the patient medical record. Baseline assessments considered standard of care completed prior to obtaining informed consent do not need to be repeated unless the investigator feels it is medically necessary.
Neurological Assessment Baseline neurological assessment is recommended in this study and will be conducted by a physician, nurse, or other allied health professional, independent of the treating physician prior to the procedure. This assessment will include the neurological signs, symptoms, and the NIH Stroke Scale. For some pre-specified subgroups, imaging studies (Carotid Duplex Ultrasound and/or Diffusion Weighted Magnetic Resonance Imaging: DW-MRI) will be performed prior to the procedure. 2. Patient Enrollment Point A patient is considered enrolled in the study if there is full compliance with the study and RoadSaver IFU eligibility criteria, and only after successful guidewire passage through the study target lesion. 3. Medications Patients enrolled in this study will be pre-medicated according to the hospital routine practice. 4. Procedure The procedure will be performed according to the physician's standard of care. During the procedure, patients should receive appropriate anticoagulation and other therapy according to standard hospital practice. The use of any medication for the treatment of vessel spasm, patient agitation or discomfort, hypotension, arrhythmias, and hemodynamic changes during the procedure is at the discretion of the investigator.
Standard procedures should be followed based on the Instructions for Use for the Roadsaver™ device of Terumo. If pre- and/or post-dilatation is performed, or any other device (e.g. embolic protection devices, etc.) is used at the investigator's discretion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •The patient has a non-occlusive and non-thrombotic carotid artery stenosis and is eligible to be treated with Roadsaver Carotid Stent as per the Instructions for Use (IFU)
- •The patient is at least 18 years of age
- •The patient has a life expectancy of at least 12 months from the date of the index procedure
- •The patient is able and willing to provide a signed IRB-/EC-approved informed consent form prior to participation
排除标准
- •Any condition that makes patient unsuitable for percutaneous transluminal angioplasty (PTA), including intolerance or allergy to any material used and accompanying therapy
结局指标
主要结局
The rate of Major Adverse Events (MAE)
时间窗: Up to 30 days
Defined as the cumulative incidence of any death or stroke up to 30 days after the index procedure.
次要结局
- Procedural success(Peri-procedural)
- Device malfunction(Peri-procedural)
- Technical Success(Peri-procedural)
- Any death(Up to 30 days)
- Minor stroke(Up to 30 days)
- Target lesion revascularization (TLR)(Up to 30 days)
- Stroke-related death(Up to 30 days)
- Major vascular and bleeding complications:(Up to 30 days)
- Major stroke(Up to 30 days)
- Transient ischemic attack(Up to 30 days)
- Any stroke(Up to 30 days)