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Recruiting Observational

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

NCT06727006 · tracked via the Priya Life Science Italy tracker
Sponsor
ASST Santi Paolo e Carlo
Phase
Observational
Started
2023-10-21
Last updated
2024-12-17

Condition(s) studied

Large Vessel OcclusionStroke AcuteThrombolysisRescue Stenting

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with large vessel occlusion strokes undergoing thrombectomy and rescue stenting within 24 hours of stroke onset * Patients ≥ 18 years of age Exclusion Criteria: * Patients \< 18 years * Refusal to give informed consent

Primary outcome measure(s)

  • Rate of symptomatic cerebral hemorrhage — 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.

Trial sites (7)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06727006 on ClinicalTrials.gov ↗ ← All trials in Italy