{
  "abstract": "Background and aims Access to mechanical thrombectomy for acute ischemic stroke secondary to large vessel occlusion (LVO) is severely restricted in resource-constrained environments, largely owing to the prohibitive cost of existing approved devices.Objective The GRASSROOT Trial is the first prospective thrombectomy study in a low- and middle-income country (LMIC) setting assessing the safety and efficacy of the novel Supernova stent retriever—engineered for highest-level performance across diverse patient populations.Methods A prospective, single-arm, multicenter trial conducted in India enrolled patients with AIS due to internal carotid artery terminus, M1/M2 middle cerebral artery, or basilar artery occlusions presenting within 24 hours of symptom onset. Primary safety endpoints were symptomatic intracranial hemorrhage (sICH) within 24 hours and all-cause mortality at 90 days. Primary efficacy endpoint was successful reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) score ≥2b), with a 90-day modified Rankin Scale (mRS) score of 0–2 serving as the secondary efficacy endpoint.Results Thirty-two consecutive eligible patients (mean age 58±16 years; 31% female; median National Institutes of Health Stroke Scale (NIHSS) score 14 (IQR 9–18), Alberta Stroke Program Early CT Score 8 (IQR 7–10)) were enrolled. Successful reperfusion (mTICI≥2b) after 1–3 passes of the Supernova stent retriever (median=1 (1–3)) was achieved in 30 (93.8%) patients without need for adjunctive rescue therapy. At 90 days, mortality was 9.4%, sICH 3.1%, and functional independence (mRS score 0–2) 50%. The median NIHSS score improved from 14 at baseline to 7 at discharge and to 4 at 90 days. First pass recanalization was observed in 22 (68.8%) patients. No device-related complications or deficiencies were observed.Conclusions The GRASSROOT Trial demonstrates excellent safety and efficacy of the Supernova stent retriever in large vessel occlusions. High rate of first pass reperfusion together with value-based pricing could facilitate a significant advancement in acute stroke thrombectomy access in India and other LMICs.Trial registration number NCT06249776.",
  "authors": [
    {
      "affiliations": [
        "Department of Neurology and Neurosurgery, University of Miami, Miami, Florida, USA"
      ],
      "name": "Dileep R Yavagal"
    },
    {
      "affiliations": [
        "Department of Neuroimaging and Interventional Neuroradiology, All India Institute of Medical Sciences, New Delhi, Delhi, India",
        "All India Institute of Medical Sciences"
      ],
      "name": "Shailesh B Gaikwad"
    },
    {
      "affiliations": [
        "Department of Neurology, All India Institute of Medical Sciences, New Delhi, India"
      ],
      "name": "Deepti Vibha"
    },
    {
      "affiliations": [
        "Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, PY, India"
      ],
      "name": "Sunil K Narayan"
    },
    {
      "affiliations": [
        "Department of Radio-Diagnosis, Jawaharlal Institute of Post Graduate Medical Education, Pondicherry, India"
      ],
      "name": "K Nagarajan"
    },
    {
      "affiliations": [
        "Department of Neurocritical Care, Apollo Hospitals, Hyderabad, Telangana, India"
      ],
      "name": "Subba Reddy Kesavarupu"
    },
    {
      "affiliations": [
        "Department of Neurological Surgery, Apollo International Hospital, Ahmadabad, India"
      ],
      "name": "Mukesh Kumar Sharma"
    },
    {
      "affiliations": [
        "Department of Interventional Neuroradiology, Seth GS Medical College & KEM Hospital, Mumbai, India"
      ],
      "name": "Rashmi Sharaf"
    },
    {
      "affiliations": [
        "Department of Neuroimaging and Interventional Radiology, NIMHANS, Bangalore, Karnataka, India"
      ],
      "name": "Sriharish Vankayalapati"
    },
    {
      "affiliations": [
        "Icahn School of Medicine at Mount Sinai, New York, New York, USA"
      ],
      "name": "Amol Mehta"
    },
    {
      "affiliations": [
        "Department of Neurology, Institute of Postgraduate Medical Education and Research, Kolkata, India",
        "Department of Neurology, Woodlands Multispeciality Hospital, Kolkata, West Bengal, India"
      ],
      "name": "Deep Das"
    },
    {
      "affiliations": [
        "P D Hinduja Hospital and Medical Research Center, Mumbai, MH, India"
      ],
      "name": "Darshan Doshi"
    },
    {
      "affiliations": [
        "Nanavati Hospital Super Speciality Hospital, Mumbai, MH, India"
      ],
      "name": "Pradyumna Oak"
    },
    {
      "affiliations": [
        "Nanavati Max Super Speciality Hospital, Mumbai, MH, India"
      ],
      "name": "Manish Salunkhe"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, JFK Health System, Edison, New Jersey, USA"
      ],
      "name": "Brian Jankowitz"
    },
    {
      "affiliations": [
        "Department of Interventional Neuroradiology, West Virginia University Rockefeller Neuroscience Institute, Morgantown, West Virginia, USA"
      ],
      "name": "Ansaar T Rai"
    },
    {
      "affiliations": [
        "Bright Research Partners, Minneapolis, Minnesota, USA"
      ],
      "name": "Scott B Brown"
    },
    {
      "affiliations": [
        "Department of Neurology, University of Toledo Health Science Campus, Toledo, Ohio, USA"
      ],
      "name": "Syed F Zaidi"
    },
    {
      "affiliations": [
        "Department of Neurology, Medical College of Wisconsin and Froedtert Hospital, Milwaukee, Wisconsin, USA"
      ],
      "name": "Kaiz S Asif"
    },
    {
      "affiliations": [
        "Department of Neurology, UCLA, Los Angeles, California, USA"
      ],
      "name": "David S Liebeskind"
    },
    {
      "affiliations": [
        "Department of Neurology, Cooper University Hospital, Camden, New Jersey, USA"
      ],
      "name": "Tudor G Jovin"
    },
    {
      "affiliations": [
        "Department of Neurology, Christian Medical College and Hospital Ludhiana, Ludhiana, PB, India"
      ],
      "name": "Jeyaraj Pandian"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona, USA"
      ],
      "name": "Ashutosh P Jadhav"
    },
    {
      "affiliations": [
        "Department of Neurology, Virginia Mason Medical Center, Seattle, Washington, USA"
      ],
      "name": "Kunakorn Atchaneeyasakul"
    },
    {
      "affiliations": [
        "HonorHealth Research Institute, Scottsdale, Arizona, USA"
      ],
      "name": "Shashvat Desai"
    },
    {
      "affiliations": [
        "Department of Radiodiagnosis, Yashoda Super Specialty Hospitals Secunderabad, Secunderabad, Telangana, India"
      ],
      "name": "Suresh Giragani"
    },
    {
      "affiliations": [],
      "name": "GRASSROOT Trial investigators"
    }
  ],
  "title": "Mechanical thrombectomy for acute ischemic stroke in a low- and middle-income country: primary outcomes from the GRASSROOT Trial",
  "uid": "c3879a56-5da4-5b1b-ba94-d854e66823ab"
}