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Abstract
Background Mechanical thrombectomy (MT) has become a standard treatment for acute ischemic strokes (AIS). However, MT failure occurs in approximately 10–30% of cases, leading to severe repercussions (with mortality rates up to 40% according to observational data). Among the available rescue techniques, rescue intracranial stenting (RIS) appears as a promising option.
Objective This trial is poised to demonstrate the superiority of RIS in addition to the best medical treatment (BMT) in comparison with BMT alone, in improving the functional outcomes at 3 months for patients experiencing an AIS due to a large vessel occlusion refractory to MT (rLVO).
Methods Permanent Intracranial STenting for Acute Refractory large vessel occlusions (PISTAR) is a multicenter prospective randomized open, blinded endpoint trial conducted across 11 French University hospitals. Adult patients (≥18 years) with an acute intracranial occlusion refractory to standard MT techniques will be randomized 1:1 during the procedure to receive either RIS+BMT (intervention arm) or BMT alone (control arm).
Results The primary outcome is the rate of good clinical outcome at 3 months defined as a modified Rankin Scale score ≤2 and evaluated by an independent assessor blinded to the randomization arm. Secondary outcomes include hemorrhagic complications, all adverse events, and death. The number of patients to be included is 346. Two interim analyses are planned with predefined stopping rules.
Conclusion The PISTAR trial is the first randomized controlled trial focusing on the benefit of RIS in rLVOs. If positive, this study will open new insights into the management of AIS.
Trial registration number NCT06071091.
- Stroke
- Thrombectomy
- Stent
- Atherosclerosis
Data availability statement
Data are available upon reasonable request.
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Data availability statement
Data are available upon reasonable request.
Footnotes
Correction notice Since this article first published, the affiliation for the author Agnes Dechartres has been updated.
Contributors All participating authors have significantly contributed to the research. The corresponding author ensured that appropriate permissions were obtained; and acts as the guarantor of this article. The corresponding author accepts full responsibility for the content and conduct of the study, had access to the data, and made the decision to publish. KP designed, drafted, and revised the paper. He is the guarantor. AD and AB planned statistical analysis, designed the trial, and revised the paper. AG, MM, LS, CD, TT, HHo, BL, FDM, NB, HHe, BG, SR, CC, AC, SV, ML, VC, CA, GM, IS, SL, ES, JA, NS, VD, SA collected data and revised the paper. FC designed the trial, revised the paper, and provided structural overview of the project.
Funding This trial is funded by a national public grant: PHRC-IR (Programme Hospitalier de Recherche Clinique Interrégional); PHRC # APHP210091. Free devices (intracranial stent systems) are provided by one exclusive manufacturer (Stryker Neurovascular). This company holds no role in the conception of the study; nor will it participate in the data collection, analysis, interpretation of results, or decision to publish.
Competing interests NS reports a conflict of interest with Medtronic, Balt Extrusion, Microvention (consultant). FC reports a conflict of interest with Medtronic, Balt Extrusion (consultant), ClinSearch (core laboratory), Penumbra, Stryker (payment for reading), and Artedrone (board). The other authors report no conflicts of interest.
Provenance and peer review Not commissioned; externally peer reviewed.
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