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NCT Number: NCT06727006

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Papa Giovanni XXIII, Bergamo, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. modified Rankin Scale (mRS)

    Time frame: 3 months

    mRS, a 6-level, clinician-reported, measure of global disability, with 0 being no symptoms and 6 being death. mRS is dichotomized where good functional outcome is a score 0 - 2 and poor functional outcome 3-6.

Other outcomes

  1. Rate of Stent Thrombosis

    Time frame: 24 hours

    Acute stent thrombosis

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Ballabio, Medical Doctor

CONTACT

[email protected]

+393470772687

Luca Valvassori, MD

CONTACT

[email protected]

+393395947715

Sponsors and collaborators

Lead sponsor

ASST Santi Paolo e Carlo

Other

Registry information

Official study title

Stroke, Thrombolysis and Rescue Stenting

Acronym: STARS

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 10, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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