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

December 14, 2024 updated by: Elena Ballabio, ASST Santi Paolo e Carlo

Stroke, Thrombolysis and Rescue Stenting

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bergamo, Italy, 24127
        • Recruiting
        • Asst Papa Giovanni XXIII
        • Contact:
          • Luca Quilici, MD
        • Contact:
          • Marcella Vedovello, MD
      • Cesena, Italy, 47023
        • Recruiting
        • Ospedale Bufalini
        • Contact:
          • Marco Longoni, MD
        • Contact:
          • Sebastiano Giacomozzi, MD
      • Lecce, Italy, 73100
        • Recruiting
        • Azienda Sanitaria Lecce - Ospedale "Vito Fazzi"
        • Contact:
          • Emilio Lozupone, MD
      • Milan, Italy, 20162
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
        • Contact:
          • Mariangela Piano, MD
        • Contact:
          • Antonio Macera, MD
      • Milan, Italy, 20153
      • Monza, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
        • Contact:
          • Paolo Remida, MD
        • Contact:
          • Susanna Diamanti, MD
      • Pietra Ligure, Italy, 17100
        • Recruiting
        • ASL 2 Savonese - Ospedale Santa Corona
        • Contact:
          • Valentina Saia, MD
        • Contact:
          • Antioco Sanna, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients with acute large vessel occlusion strokes undergoing rescue stenting in participating hospitals.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with acute large vessel occlusion stroke undergoing rescue stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of symptomatic cerebral hemorrhage
Time Frame: 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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale (mRS)
Time Frame: 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.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Stent Thrombosis
Time Frame: 24 hours
Acute stent thrombosis
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASST Santi Paolo e Carlo

Investigators

  • Principal Investigator: Elena Ballabio, MD, ASST Santi Paolo e Carlo
  • Study Director: Luca Valvassori, MD, ASST Santi Paolo carlo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 14, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STARS12042023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD used in the results publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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