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

Stroke, Thrombolysis and Rescue Stenting

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06727006
Acronym
STARS
Enrollment
400
Registered
2024-12-10
Start date
2023-10-21
Completion date
2027-03-31
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Large Vessel Occlusion, Rescue Stenting, Stroke Acute, Thrombolysis

Keywords

Rescue stenting, Thrombolysis

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.

Interventions

None listed

Sponsors

ASST Santi Paolo e Carlo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Rate of symptomatic cerebral hemorrhage24 hoursSymptomatic 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

MeasureTime frameDescription
modified Rankin Scale (mRS)3 monthsmRS, 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

MeasureTime frameDescription
Rate of Stent Thrombosis24 hoursAcute stent thrombosis

Countries

Italy

Contacts

Primary ContactElena Ballabio, Medical Doctor
elena.ballabio@asst-santipaolocarlo.it+393470772687
Backup ContactLuca Valvassori, MD
luca.valvassori@asst-santipaolocarlo.it+393395947715

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026