Related Experiment Video
Updated: May 9, 2026
The Stroke Preclinical Assessment Network Multi-Laboratory Model of Thromboembolic Stroke with Thrombolysis: TE-MCAo
Published on: December 19, 2025
Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute
Vitor M Pereira1, Jan Gralla, Antoni Davalos
1From the Department of Neuroradiology (V.M.P.), and Department of Neurology (R.S.), University Hospital of Geneva, Geneva, Switzerland; Department for Diagnostic and Interventional Neuroradiology (J.G., G.S.), and Department of Neurology (M.A.), Inselspital, University of Bern, Bern, Switzerland; Department of Neurology (A.D.), and Department of Neuroradiology (C.C.), University Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain; Department of Neuroradiology, CHU de Montpellier - Guy de Chauliac, Montpellier, France (A.B.); Department of Neuroradiology, Alfred Krupp Krankenhaus, Essen, Germany (R.C.); Department of Neurology, UCLA Stroke Center, CA (D.S.L.); Department of Neurology, Emory University School of Medicine, Atlanta, GA (R.G.N.); Department of Neuroradiology, University Hospital of Cologne, Cologne, Germany (T.L.); Department for Neuroradiology, University of Calgary, Foothills Medical Centre, Calgary, AB, Canada (M.G.); Department of Neurology, Klinikum Osnabrueck, Osnabrueck, Germany (M.B.); and Department of Neuroradiology, Hospital Virgen de la Arrixaca, Murcia, Spain (A.M.).
Background And Purpose:
Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire Flow Restoration in patients with acute ischemic stroke.
Methods:
Solitaire Flow Restoration Thrombectomy for Acute Revascularization was an international, multicenter, prospective, single-arm study of Solitaire Flow Restoration thrombectomy in patients with large vessel anterior circulation strokes treated within 8 hours of symptom onset. Strict criteria for site selection were applied. The primary end point was the revascularization rate (thrombolysis in cerebral infarction ≥2b) of the occluded vessel as determined by an independent core laboratory. The secondary end point was the rate of good functional outcome (defined as 90-day modified Rankin scale, 0-2).
Results:
A total of 202 patients were enrolled across 14 comprehensive stroke centers in Europe, Canada, and Australia. The median age was 72 years, 60% were female patients. The median National Institute of Health Stroke Scale was 17. Most proximal intracranial occlusion was the internal carotid artery in 18%, and the middle cerebral artery in 82%. Successful revascularization was achieved in 79.2% of patients. Device and procedure-related severe adverse events were found in 7.4%. Favorable neurological outcome was found in 57.9%. The mortality rate was 6.9%. Any intracranial hemorrhagic transformation was found in 18.8% of patients, 1.5% were symptomatic.
Conclusions:
In this single-arm study, treatment with the Solitaire Flow Restoration device in intracranial anterior circulation occlusions results in high rates of revascularization, low risk of clinically relevant procedural complications, and good clinical outcomes in combination with low mortality at 90 days.
Clinical Trial Registration Url:
http://www.clinicaltrials.gov. Unique identifier: NCT01327989.
