Rescue Stenting and Intravenous Thrombolysis In Patients With Large Vessel Ischemic Stroke

Официальное название

Stroke, Thrombolysis and Rescue Stenting

Обзор

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.

Первичные конечные точки

• Rate of symptomatic cerebral hemorrhage [Срок оценки: 24 hours]

Вторичные конечные точки (1)

• modified Rankin Scale (mRS) [Срок оценки: 3 months]

Критерии участия

Критерии включения

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

Критерии исключения

• Patients < 18 years
• Refusal to give informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 7 центров

• ASST Papa Giovanni XXIII — Bergamo
• Ospedale Bufalini — Cesena
• Azienda Sanitaria Lecce - Ospedale "Vito Fazzi" — Lecce
• ASST Santi Paolo e Carlo — Milan
• ASST Grande Ospedale Metropolitano Niguarda — Milan
• Fondazione IRCCS San Gerardo dei Tintori — Monza
• ASL 2 Savonese - Ospedale Santa Corona — Pietra Ligure

Публикации

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Идентификаторы

NCT: NCT06727006 · STARS12042023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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