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临床试验/NCT06727006
NCT06727006招募中不适用

Stroke, Thrombolysis and Rescue Stenting

ASST Santi Paolo e Carlo7 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
7
主要终点
Rate of symptomatic cerebral hemorrhage

研究概览

简要总结

Intravenous thrombolysis (IVT) and mechanical thrombectomy (MT) are the standard of care for treating selected patients with acute large-vessel occlusion stroke (LVOS). Successful revascularization is strongly correlated with favorable outcomes. Nevertheless, recanalization failure with stent retrieval and contact aspiration has been observed in up to 29% of patients. If primary thrombectomy fails to achieve recanalization, rescue stenting (RS) has proven to be a feasible rescue therapy. Currently, approved evidence-based alternatives for LVOS patients who have failed MT are lacking, but permanent stenting is suggested as a rescue treatment in expert consensus statements.

Dual antiplatelet therapy (DAPT), typically consisting of clopidogrel and aspirin, is recommended after stent implantation to reduce the risk of stent thrombosis; however, these medications are not suitable in the acute setting, and optimal platelet inhibition strategies remain unclear. Glycoprotein (GP) IIb/IIIa receptor inhibitors have intravenous administration, a rapid onset of action, and their effects subside within a few hours after discontinuation. For these reasons, an increasing number of studies have investigated their use in conjunction with primary stenting for acute stroke. Currently, there is no evidence supporting the superiority of any particular antithrombotic strategy, so decisions are guided by clinical judgment.

An additional challenge for clinicians arises when IVT is combined with stenting. Stroke guidelines recommend starting antiplatelets 24 hours after IVT and the risk associated with antithrombotic therapy within the first 24 hours after IVT remains uncertain.

This is multicenter, prospective, observational study of patients with LVOS undergoing mechanical thrombectomy and rescue stenting. The aim of this study is to evaluate real-world antithrombotic strategies in emergency stenting, particularly in patients treated with IVT, and to assess the safety of emergent stenting following intravenous thrombolysis.

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

入选标准

  • Patients with large vessel occlusion strokes undergoing thrombectomy and rescue stenting within 24 hours of stroke onset
  • Patients ≥ 18 years of age

排除标准

  • Patients < 18 years
  • Refusal to give informed consent

结局指标

主要结局

Rate of symptomatic cerebral hemorrhage

时间窗: 24 hours

Symptomatic intracerebral hemorrhage (sICH) was defined as a worsening in National Institutes of Health Stroke Scale (NIHSS) score of ≥4 points within 24 hours with evidence of any hemorrhage on follow-up neuroimaging.

次要结局

  • modified Rankin Scale (mRS)(3 months)

研究者

发起方
ASST Santi Paolo e Carlo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Ballabio

Full time dependent Neurologist Doctor. Working at neurologica department at ASST-Santi Paolo e Carlo at Milan-Italy

ASST Santi Paolo e Carlo

研究点 (7)

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