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RECRUITING
NCT06727006

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

Sponsor: ASST Santi Paolo e Carlo

View on ClinicalTrials.gov

Summary

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.

Official title: Stroke, Thrombolysis and Rescue Stenting

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2023-10-21

Completion Date

2027-03

Last Updated

2024-12-17

Healthy Volunteers

No

Locations (7)

ASST Papa Giovanni XXIII

Bergamo, Italy, Italy

Ospedale Bufalini

Cesena, Italy, Italy

Azienda Sanitaria Lecce - Ospedale "Vito Fazzi"

Lecce, Italy, Italy

ASST Santi Paolo e Carlo

Milan, Italy, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy, Italy

ASL 2 Savonese - Ospedale Santa Corona

Pietra Ligure, Italy, Italy