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

Recruiting

• Conditions: Large Vessel Occlusion; Stroke Acute; Thrombolysis; Rescue Stenting

• Registration Number: NCT06727006
• Lead Sponsor: ASST Santi Paolo e Carlo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-21
• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-10
• Last Update Submitted: 2024-12-14
• Last Update Posted: 2024-12-17
• Primary Completion: 2026-12
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of symptomatic cerebral hemorrhage	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 Outcome Measures

Name	Time	Method
modified Rankin Scale (mRS)	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.

Trial Locations

Locations (7)

Ospedale Bufalini; 🇮🇹 Cesena, Italy

ASST Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

Azienda Sanitaria Lecce - Ospedale "Vito Fazzi"; 🇮🇹 Lecce, Italy

ASST Santi Paolo e Carlo; 🇮🇹 Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milan, Italy

Fondazione IRCCS San Gerardo dei Tintori; 🇮🇹 Monza, Italy

ASL 2 Savonese - Ospedale Santa Corona; 🇮🇹 Pietra Ligure, Italy