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Clinical Trials/NCT06727006
NCT06727006
Recruiting
Not Applicable

Stroke, Thrombolysis and Rescue Stenting

ASST Santi Paolo e Carlo7 sites in 1 country400 target enrollmentOctober 21, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Large Vessel Occlusion
Sponsor
ASST Santi Paolo e Carlo
Enrollment
400
Locations
7
Primary Endpoint
Rate of symptomatic cerebral hemorrhage
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 21, 2023
End Date
March 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
ASST Santi Paolo e Carlo
Responsible Party
Principal Investigator
Principal Investigator

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

Eligibility Criteria

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

Outcomes

Primary Outcomes

Rate of symptomatic cerebral hemorrhage

Time Frame: 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.

Secondary Outcomes

  • modified Rankin Scale (mRS)(3 months)

Study Sites (7)

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