Rescue Stenting and Intravenous Thrombolysis in Patients with Large Vessel Ischemic Stroke

Last updated: December 14, 2024
Sponsor: ASST Santi Paolo e Carlo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT06727006
STARS12042023
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Patients with large vessel occlusion strokes undergoing thrombectomy and rescuestenting within 24 hours of stroke onset

  • Patients ≥ 18 years of age

Exclusion

Exclusion Criteria:

  • Patients < 18 years

  • Refusal to give informed consent

Study Design

Total Participants: 400
Study Start date:
October 21, 2023
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • ASST Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Active - Recruiting

  • Ospedale Bufalini

    Cesena, 47023
    Italy

    Active - Recruiting

  • Azienda Sanitaria Lecce - Ospedale "Vito Fazzi"

    Lecce, 73100
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162
    Italy

    Active - Recruiting

  • ASST Santi Paolo e Carlo

    Milan, 20153
    Italy

    Active - Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900
    Italy

    Active - Recruiting

  • ASL 2 Savonese - Ospedale Santa Corona

    Pietra Ligure, 17100
    Italy

    Active - Recruiting

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