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NCT06727006Recruiting

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

Stroke, Thrombolysis and Rescue Stenting

Source: ClinicalTrials.gov · Last updated 17 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
5 Dec 2024
Start date
21 Oct 2023
Primary completion date
Dec 2026
Lead sponsor
ASST Santi Paolo e Carlo
Diseases
Stroke
NCT number
NCT06727006

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 21 Oct 2023 to the primary completion date, Dec 2026
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Patients \< 18 years

Other

  • Refusal to give informed consent

Who the study is looking for

  • Patients with large vessel occlusion strokes undergoing thrombectomy and rescue stenting within 24 hours of stroke onset
  • Patients ≥ 18 years of age

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Asst Papa Giovanni XXIII
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BergamoItalyRecruiting
Ospedale Bufalini
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CesenaItalyRecruiting
Azienda Sanitaria Lecce - Ospedale "Vito Fazzi"
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LecceItalyRecruiting
Asst Santi Paolo E Carlo
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MilanItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyRecruiting
ASL 2 Savonese - Ospedale Santa Corona
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Pietra LigureItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.