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

A

ASST Santi Paolo e Carlo

Status

Enrolling

Conditions

Large Vessel Occlusion
Rescue Stenting
Thrombolysis
Stroke Acute

Study type

Observational

Funder types

Other

Identifiers

NCT06727006
STARS12042023

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

Patients with acute large vessel occlusion stroke undergoing rescue stenting

Trial contacts and locations

7

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Central trial contact

Luca Valvassori, MD; Elena Ballabio, Medical Doctor

Data sourced from clinicaltrials.gov

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