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Large Vessel OcclusionSTARSNCT06727006

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

An observational study of Large Vessel Occlusion and Stroke Acute, run by ASST Santi Paolo e Carlo at 7 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Large Vessel Occlusion, Stroke Acute, Thrombolysis
How many people
400 participants
Where
7 sitesItaly
Study dates
21 Oct 2023to Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patients < 18 years
  • Refusal to give informed consent

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elena Ballabio, Medical Doctor contact

+393470772687

elena.ballabio@asst-santipaolocarlo.it

Luca Valvassori, MD contact

+393395947715

luca.valvassori@asst-santipaolocarlo.it

7 sites in 1 country

Italy7 sites, 7 recruiting

  • ASST Papa Giovanni XXIII

    Bergamo, Italy, 24127

    Luca Quilici, MD

    Marcella Vedovello, MD

    Recruiting

  • Ospedale Bufalini

    Cesena, Italy, 47023

    Marco Longoni, MD

    Sebastiano Giacomozzi, MD

    Recruiting

  • Azienda Sanitaria Lecce - Ospedale "Vito Fazzi"

    Lecce, Italy, 73100

    Emilio Lozupone, MD

    Recruiting

  • ASST Santi Paolo e Carlo

    Milan, Italy, 20153

    Elena Ballabio, MD, +393470772687, elena.ballabio@asst-santipaolocarlo.it

    Luca Valvassori, MD, +393395947715, luca.valvassori@asst-santipaolocarlo.it

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Italy, 20162

    Mariangela Piano, MD

    Antonio Macera, MD

    Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Italy, 20900

    Paolo Remida, MD

    Susanna Diamanti, MD

    Recruiting

  • ASL 2 Savonese - Ospedale Santa Corona

    Pietra Ligure, Italy, 17100

    Valentina Saia, MD

    Antioco Sanna, MD

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read more

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.

Keywords
Rescue stenting, Thrombolysis
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06727006
Study groupRoleWhat they receive
Patients with acute large vessel occlusion stroke undergoing rescue stentingNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of symptomatic cerebral hemorrhage

    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.

    Measured: 24 hours

Secondary outcomes (1)

  1. modified Rankin Scale (mRS)

    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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study start21 Oct 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06727006
Sponsor's protocol ID
STARS12042023
Acronym
STARS
Status last verified
Dec 2024
First submitted
5 Dec 2024
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD used in the results publication

Publications

  • Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.

    PubMed 31662037

  • Berge E, Whiteley W, Audebert H, De Marchis GM, Fonseca AC, Padiglioni C, de la Ossa NP, Strbian D, Tsivgoulis G, Turc G. European Stroke Organisation (ESO) guidelines on intravenous thrombolysis for acute ischaemic stroke. Eur Stroke J. 2021 Mar;6(1):I-LXII. doi: 10.1177/2396987321989865. Epub 2021 Feb 19.

    PubMed 33817340

  • Heck DV, Brown MD. Carotid stenting and intracranial thrombectomy for treatment of acute stroke due to tandem occlusions with aggressive antiplatelet therapy may be associated with a high incidence of intracranial hemorrhage. J Neurointerv Surg. 2015 Mar;7(3):170-5. doi: 10.1136/neurintsurg-2014-011224. Epub 2014 Nov 11.

    PubMed 25387730

  • Baek BH, Yoon W, Lee YY, Kim SK, Kim JT, Park MS. Intravenous Tirofiban Infusion After Angioplasty and Stenting in Intracranial Atherosclerotic Stenosis-Related Stroke. Stroke. 2021 May;52(5):1601-1608. doi: 10.1161/STROKEAHA.120.033551. Epub 2021 Apr 1.

    PubMed 33793319

  • Lee JI, Gliem M, Gerdes G, Turowski B, Kaschner M, Kraus B, Hartung HP, Jander S. Safety of bridging antiplatelet therapy with the gpIIb-IIIa inhibitor tirofiban after emergency stenting in stroke. PLoS One. 2017 Dec 27;12(12):e0190218. doi: 10.1371/journal.pone.0190218. eCollection 2017.

    PubMed 29281734

  • Osteraas ND, Crowley RW, Panos N, Dafer RM. Eptifibatide use following emergent carotid stenting in acute anterior circulation ischemic stroke with tandem occlusion. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):105021. doi: 10.1016/j.jstrokecerebrovasdis.2020.105021. Epub 2020 Jun 17.

    PubMed 32807436

  • Delvoye F, Maier B, Escalard S, Labreuche J, Thion LA, Aknouche S, Hebert S, Redjem H, Smajda S, Ciccio G, Allard J, Sabben C, Obadia M, Maertens de Noordhout A, Olivot JM, Blanc R, Piotin M, Desilles JP, Mazighi M. Antiplatelet Therapy During Emergent Extracranial Internal Carotid Artery Stenting: Comparison of Three Intravenous Antiplatelet Perioperative Strategies. J Stroke Cerebrovasc Dis. 2021 Feb;30(2):105521. doi: 10.1016/j.jstrokecerebrovasdis.2020.105521. Epub 2020 Dec 9.

    PubMed 33310073

  • Naylor R, Rantner B, Ancetti S, de Borst GJ, De Carlo M, Halliday A, Kakkos SK, Markus HS, McCabe DJH, Sillesen H, van den Berg JC, Vega de Ceniga M, Venermo MA, Vermassen FEG, Esvs Guidelines Committee, Antoniou GA, Bastos Goncalves F, Bjorck M, Chakfe N, Coscas R, Dias NV, Dick F, Hinchliffe RJ, Kolh P, Koncar IB, Lindholt JS, Mees BME, Resch TA, Trimarchi S, Tulamo R, Twine CP, Wanhainen A, Document Reviewers, Bellmunt-Montoya S, Bulbulia R, Darling RC 3rd, Eckstein HH, Giannoukas A, Koelemay MJW, Lindstrom D, Schermerhorn M, Stone DH. Editor's Choice - European Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on the Management of Atherosclerotic Carotid and Vertebral Artery Disease. Eur J Vasc Endovasc Surg. 2023 Jan;65(1):7-111. doi: 10.1016/j.ejvs.2022.04.011. Epub 2022 May 20. No abstract available.

    PubMed 35598721

  • Psychogios M, Brehm A, Lopez-Cancio E, Marco De Marchis G, Meseguer E, Katsanos AH, Kremer C, Sporns P, Zedde M, Kobayashi A, Caroff J, Bos D, Lemeret S, Lal A, Arenillas JF. European Stroke Organisation guidelines on treatment of patients with intracranial atherosclerotic disease. Eur Stroke J. 2022 Sep;7(3):III-IV. doi: 10.1177/23969873221099715. Epub 2022 Jun 3.

    PubMed 36082254

  • Turc G, Bhogal P, Fischer U, Khatri P, Lobotesis K, Mazighi M, Schellinger PD, Toni D, de Vries J, White P, Fiehler J. European Stroke Organisation (ESO) - European Society for Minimally Invasive Neurological Therapy (ESMINT) Guidelines on Mechanical Thrombectomy in Acute Ischemic Stroke. J Neurointerv Surg. 2023 Aug;15(8):e8. doi: 10.1136/neurintsurg-2018-014569. Epub 2019 Feb 26.

    PubMed 30808653

  • Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.

    PubMed 26898852

  • Turc G, Tsivgoulis G, Audebert HJ, Boogaarts H, Bhogal P, De Marchis GM, Fonseca AC, Khatri P, Mazighi M, Perez de la Ossa N, Schellinger PD, Strbian D, Toni D, White P, Whiteley W, Zini A, van Zwam W, Fiehler J. European Stroke Organisation (ESO)-European Society for Minimally Invasive Neurological Therapy (ESMINT) expedited recommendation on indication for intravenous thrombolysis before mechanical thrombectomy in patients with acute ischemic stroke and anterior circulation large vessel occlusion. J Neurointerv Surg. 2022 Mar;14(3):209. doi: 10.1136/neurintsurg-2021-018589. Epub 2022 Feb 3.

    PubMed 35115395

Questions about this trial

What is this clinical trial studying?

An observational study of Large Vessel Occlusion and Stroke Acute, run by ASST Santi Paolo e Carlo at 7 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elena Ballabio, Medical Doctor (+393470772687, elena.ballabio@asst-santipaolocarlo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of symptomatic cerebral hemorrhage (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06727006, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

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