Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial (GRASSROOT)

Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial (GRASSROOT)

The study aims to evaluate the safety and efficacy of the Supernova stent retriever device, developed by Gravity Medical Technology, for treating acute ischemic stroke. The device is used to remove blood clots and restore blood flow to the brain .

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ischemic Stroke
• Intervention / Treatment: Device: Supernova revascularization device

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • Marengo CIMS Hospital
  • Maharashtra
    • Mumbai, Maharashtra, India, 400016
      • P.D. Hinduja Hospital and Medical Research Centre
    • Mumbai, Maharashtra, India, 400056
      • Dr Balabhai Nanavati Hospital
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110029
      • All India Institute of Medical Sciences, New Delhi
  • Puducherry
    • Puducherry, Puducherry, India, 605006
      • Jawaharlal Institute Of Postgraduate Medical Education And Research
  • Telangana
    • Hyderabad, Telangana, India, 500096
      • Apollo Hospitals
    • Hyderabad, Telangana, India, 500082
      • Yashoda Hospitals, Secunderabad
    • Hyderabad, Telangana, India, 500082
      • Yashoda Hospitals, Somajiguda
  • West Bengal
    • Kolkata, West Bengal, India, 700027
      • The Calcutta Medical Research Institute
• Iran
  • Tehran Province
    • Tehran, Tehran Province, Iran, 1416753955
      • Tehran University of Medical Sciences
• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75510
      • National Institute of Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. New focal neurologic deficit consistent with being of acute cerebral ischemia origin.
2. Age 18-85 years old (inclusive).
3. Interventionalists estimate that treatment with the Supernova (first deployment in target vessel) can be achieved within 24 hours of symptom onset.
4. Intravenous thrombolysis may be given as per national guidelines and patients receiving or not receiving intravenous thrombolysis will both be eligible for inclusion in the study.
5. Admission NIH Stroke Scale score of 8-25
6. No known significant pre-stroke disability (pre-stroke mRS 0 or 1).
7. Catheter angiographic confirmation of large vessel occlusion in the intracranial internal carotid artery, the M1 or M2 segments of the middle cerebral artery, or the basilar artery that is accessible to the Supernova device.

8. For strokes in the anterior circulation, the following imaging criteria should also be met:

   1. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL, OR
   2. CT criterion: ASPECTS 6 to 10 on baseline NCCT
9. Anticipated life expectancy of at least 6 months.
10. A signed informed consent by the patient or a Legally Authorized Representative or independent physician in case of oral consent.

Exclusion Criteria:

1. Subject already participating in another study of an investigational treatment device or treatment.
2. Use any other intra-arterial recanalization drug or device prior to the use of Supernova (Supernova is not the first-choice device).
3. Angiographically evident excessive arterial tortuosity precluding device access to the thrombus.
4. For all patients, severe sustained hypertension with SBP >220 and/or DBP >120; for patients treated with IV tPA, sustained hypertension despite treatment with SBP >185 and/or DBP > 110.
5. Glucose < 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L).
6. Known hemorrhagic diathesis.
7. Coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 3.0.
8. Treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal.
9. Patients who have received a direct thrombin inhibitor within the last 48 hours; must have a partial thromboplastin time (PTT) less than 1.5 times the normal to be eligible.
10. Platelet count of less than 50,000/ µL.
11. History of severe allergy to contrast medium, nickel, or Nitinol.
12. Intracranial hemorrhage.
13. Significant mass effect with midline shift.
14. Intracranial tumor (apart from small meningioma, ≤ 2 cm in diameter).
15. Stenosis or any occlusion in the deployment site or in a proximal vessel requiring treatment or preventing device access to the thrombus (for example, stenosis or occlusion in the cervical internal carotid artery or common carotid artery).
16. Presence of intracranial atherosclerotic disease requiring rescue therapy (for example, intracranial stenting).
17. Females who are pregnant or breastfeeding.
18. Known current use of narcotic drugs at the time of treatment.
19. Prior recent stroke in the past 3 months.
20. Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30.
21. Known cerebral vasculitis.
22. Rapidly improving neurological status defined as the improvement of greater than 8 points on the NIHSS or improvement to NIHSS of < 6 prior to the procedure.
23. Clinical symptoms are suggestive of bilateral stroke or stroke in multiple territories.
24. Ongoing seizure due to stroke.
25. Evidence of active systemic infection.
26. Known cancer with metastases.
27. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
28. Evidence of dissection in the extra or intracranial cerebral arteries.
29. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation or anterior/posterior circulation).
30. Aneurysm in the target vessel.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supernova revascularization device; Mechanical thrombectomy with Supernova Stent Retriever	Device: Supernova revascularization device; Mechanical Thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful reperfusion	Rate of successful reperfusion, defined as modified Thrombolysis in Cerebral Ischemia (mTICI) grade of 2b or higher Grade 0: No reperfusion Grade 3: Complete reperfusion	Day 0 (end of procedure)
Symptomatic intracranial hemorrhage	Safety (Rate of symptomatic intracranial hemorrhage (sICH) as measured by the SITS-MOST criteria) The SITS-MOST definition of SICH is a local or remote type II parenchymal haemorrhage within 22 to 36 hours after treatment (or sooner) associated with a ≥ fourpoint deterioration on the NIHSS score from baseline or from the lowest score from baseline to 24 hours, or leading to death.	sICH measured within 24 (18-36) hours of the study procedure
All-cause mortality	Safety (All-cause mortality)	All-cause mortality measured at 90 (±14) days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with a modified Rankin Scale (mRS) score of ≤2	Effectiveness (The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead)	90 (±14) days post-treatment
Successful Reperfusion at First Pass	Effectiveness (Successful reperfusion defined as mTICI 2b or better at first pass)	Assessed at first pass of the intervention during the procedure
Asymptomatic Intracranial Hemorrhage	Safety (Incidence of any asymptomatic intracranial hemorrhage post-procedure)	Day 1 (within 24 hours (18-36 hours) of the procedure)
Neurological Deterioration	Safety (defined as a ≥4-point increase in the National Institutes of Health Stroke Scale (NIHSS) score)	Day 1 (within 24 hours (18-36 hours) of the procedure)

Collaborators and Investigators

• Sponsor: Gravity Medical Technology, INC
• Investigators: Study Chair: Dileep R. Yavagal, MD, MBBS, University of Miami & Jackson Memorial Hospitals

Publications and helpful links

General Publications

• Yavagal DR, Gaikwad SB, Vibha D, Narayan SK, Nagarajan K, Kesavarupu SR, Sharma MK, Sharaf R, Vankayalapati S, Mehta A, Das D, Doshi D, Oak P, Salunkhe M, Jankowitz B, Rai AT, Brown SB, Zaidi SF, Asif KS, Liebeskind DS, Jovin TG, Pandian J, Jadhav AP, Atchaneeyasakul K, Desai S, Giragani S; GRASSROOT Trial investigators; GRASSROOT trial investigators GRASSROOT Trial investigators. Mechanical thrombectomy for acute ischemic stroke in a low- and middle-income country: primary outcomes from the GRASSROOT Trial. J Neurointerv Surg. 2025 Dec 10:jnis-2025-024470. doi: 10.1136/jnis-2025-024470. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Actual): April 14, 2026
• Study Completion (Actual): April 14, 2026

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Revascularization; Brain; Reperfusion; Mechanical thrombectomy; Brain clot; Brain infarction; Cerebral ischemia; Neurovascular intervention; Stent retriever; Supernova; Gravity Medical Technology
• Additional Relevant MeSH Terms: Pathologic Processes; Infarction; Necrosis; Ischemia; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Stroke; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Nervous System Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Brain Ischemia; Brain Infarction
• Other Study ID Numbers: GMT-GRASSROOT-24-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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