Stenting for Ischemic Strokes Secondary to Medically Refractory Intracranial Atherosclerotic Disease: STRICT-ICAS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Recurrent ischemic stroke within treated territory, ICH, or death
研究概览
简要总结
The goal of this observational study is to establish a prospective multicenter registry of patients undergoing intracranial stenting for ischemic strokes caused by medically refractory ICAD. The study aims to evaluate current practice patterns, periprocedural outcomes, and delayed outcomes.
Researchers will collect demographic and procedural data from patients who undergo intracranial stenting after having an ischemic stroke caused by medically refractory ICAD.
详细描述
Background: Intracranial atherosclerotic disease (ICAD) accounts for approximately 10% of ischemic strokes in the United States and is a major cause of recurrent strokes. Although three randomized controlled trials (RCT) have failed to show the benefit of endovascular treatment [1-3], there exists a subset of patients who experience recurrent strokes despite maximum medical therapy. These patients may benefit from Percutaneous Angioplasty and Stenting (PTAS), especially when selecting flow-related stroke subtypes rather than perforator or embolic strokes or patients with recurrent transient ischemic attacks. A follow-up post-market surveillance study mandated by the FDA to evaluate peri-procedural safety of the Wingspan Stent (Stryker, Kalamazoo, MI) demonstrated reduced perioperative stroke and death rates, further suggesting that patients could benefit from PTAS.[4] The experience of neurointerventionalists and proper patient selection were the main reported factors for a lower periprocedural stroke and death rate in the WEAVE trial in comparison to the SAMMPRIS trial.
The practice pattern of endovascular treatment for medically refractory ICAD has been evolving since the publication of the WEAVE trial with an increasing off-label utilization of balloon-mounted coronary stents or other self-expanding stents. Since the publication of the three negative RCTs, there has been a lack of prospective data regarding current endovascular practice patterns for ICAD. There is likely variation in patient selection, timing of intervention, and devices used. Analyzing these may provide insight into optimal practices for the endovascular treatment of ICAD and the design of future trials.
Study Population: Consecutive patients with ischemic strokes caused by medically refractory ICAD undergoing intracranial stenting, and meeting study inclusion criteria will be included.
Study Intervention/Product and its Intended Use: Participating centers will follow their standard of care protocols for intracranial stenting for medically refractory ICAD. Investigators will not advertise use of any specific on-label or off-label device for intracranial stenting. No new products will be studied or promoted.
Objectives/Endpoints:
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
- •Adult patients with ICAD resulting in 70-99% vessel stenosis who undergo PTAS with any device
- •Patients will have to experience a stroke despite medical management involving risk factor modification and an antiplatelet agent
- •Baseline modified Rankin Scale (mRS) ≤ 3
- •Performance of the endovascular procedure at least 3 days after the last stroke
排除标准
- •Large vessel occlusion strokes undergoing rescue intracranial stenting will not be included
- •Baseline modified Rankin Scale (mRS) >3
- •Performance of the endovascular procedure less than 3 days after the last stroke.
- •Patients undergoing intracranial stenting for first stroke caused by ICAD
- •Adult patients with ICAD resulting in <70% vessel stenosis
结局指标
主要结局
Recurrent ischemic stroke within treated territory, ICH, or death
时间窗: 72 hours post procedure
Recurrent ischemic stroke within the territory treated, intracranial hemorrhage, or death within 72 hours after the procedure. All of the patients enrolled in the trial will be assessed at 72 hours post-stenting either in the hospital by the study interventionalist or, if the patient had already been discharged home, by telephone interview by a core study nurse or interventionalist.
Stroke, ICH, or neurological death in treated territory
时间窗: 6 months to 1 year post procedure
Stroke within the territory treated, intracranial hemorrhage, or neurologic death within 6 months to 1 year after PTAS. All the patient enrolled in the trial will undergo * Follow up clinic visit between 6 months to 1 year per standard of care * Follow up vascular imaging (modality of imaging will be decided based on standard of care at participating centers)
次要结局
- Stent patency(6 months to 1 year post procedure)
- Re-stenosis ≥ 70%(6 months to 1 year post procedure)
- mRS(6 months to 1 year post procedure)
- Mortality(1 year post procedure)
- Myocardial infarction(72 hours post procedure)
研究者
Nitin Goyal
Co-Principal Investigator
Semmes-Murphey Foundation