NCT06727006 Rescue Stenting and Intravenous Thrombolysis In Patients With Large Vessel Ischemic Stroke
| NCT ID | NCT06727006 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ASST Santi Paolo e Carlo |
| Condition | Large Vessel Occlusion |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-10-21 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-10-21 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Elena Ballabio, MD
PRINCIPAL INVESTIGATOR
ASST Santi Paolo e Carlo
Frequently Asked Questions
Who can join the NCT06727006 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Large Vessel Occlusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06727006 currently recruiting?
Yes, NCT06727006 is actively recruiting participants. Contact the research team at elena.ballabio@asst-santipaolocarlo.it for enrollment information.
Where is the NCT06727006 trial being conducted?
This trial is being conducted at Bergamo, Italy, Cesena, Italy, Lecce, Italy, Milan, Italy and 3 additional locations.
Who is sponsoring the NCT06727006 clinical trial?
NCT06727006 is sponsored by ASST Santi Paolo e Carlo. The principal investigator is Elena Ballabio, MD at ASST Santi Paolo e Carlo. The trial plans to enroll 400 participants.