ClinicalTrials.gg
CompletedNCT06249776GRASSROOTUpdated May 22, 2026

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

An interventional study of Supernova revascularization device in Ischemic Stroke, Stroke and Cerebrovascular Disorders, sponsored by Gravity Medical Technology, INC. Completed at 11 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Gravity Medical Technology, INC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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 .

02

Conditions studied

  • Ischemic Stroke
  • Stroke
  • Cerebrovascular Disorders
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Vascular Diseases
  • Cardiovascular Diseases

Keywords

  • Mechanical thrombectomy
  • Brain
  • Brain clot
  • Brain infarction
  • Cerebral ischemia
  • Neurovascular intervention
  • Revascularization
  • Reperfusion
  • Stent retriever
  • Supernova
  • Stroke
  • Gravity Medical Technology
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's enrollment of 55 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Gravity Medical Technology, INC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 of at least 6 months.
  10. A signed by the patient or a Legally Authorized Representative or independent physician in case of oral consent.

Exclusion criteria

Exclusion Criteria:

  1. Subject already participating in another study of an 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 (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. 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 (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 .
  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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Supernova revascularization device

    Mechanical thrombectomy with Supernova Stent Retriever

    Device: Supernova revascularization device

Interventions

  • DeviceSupernova revascularization device

    Mechanical Thrombectomy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 0 (end of procedure)

  2. 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.

    Time frame: sICH measured within 24 (18-36) hours of the study procedure

  3. All-cause mortality

    Safety (All-cause mortality)

    Time frame: All-cause mortality measured at 90 (±14) days

Secondary outcomes

  1. 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)

    Time frame: 90 (±14) days post-treatment

  2. Successful Reperfusion at First Pass

    Effectiveness (Successful reperfusion defined as mTICI 2b or better at first pass)

    Time frame: Assessed at first pass of the intervention during the procedure

  3. Asymptomatic Intracranial Hemorrhage

    Safety (Incidence of any asymptomatic intracranial hemorrhage post-procedure)

    Time frame: Day 1 (within 24 hours (18-36 hours) of the procedure)

  4. Neurological Deterioration

    Safety (defined as a ≥4-point increase in the National Institutes of Health Stroke Scale (NIHSS) score)

    Time frame: Day 1 (within 24 hours (18-36 hours) of the procedure)

07

Study locations

11 sites
  • Marengo CIMS Hospital
    Ahmedabad, Gujarat 380060, India
  • P.D. Hinduja Hospital and Medical Research Centre
    Mumbai, Maharashtra 400016, India
  • Dr Balabhai Nanavati Hospital
    Mumbai, Maharashtra 400056, India
  • All India Institute of Medical Sciences, New Delhi
    New Delhi, National Capital Territory of Delhi 110029, India
  • Jawaharlal Institute of Postgraduate Medical Education and Research
    Puducherry, Puducherry 605006, India
  • Yashoda Hospitals, Secunderabad
    Hyderabad, Telangana 500082, India
  • Yashoda Hospitals, Somajiguda
    Hyderabad, Telangana 500082, India
  • Apollo Hospitals
    Hyderabad, Telangana 500096, India
  • The Calcutta Medical Research Institute
    Kolkata, West Bengal 700027, India
  • Tehran University of Medical Sciences
    Tehran, Tehran Province 1416753955, Iran
  • National Institute of Cardiovascular Diseases
    Karachi, Sindh 75510, Pakistan
08

References and documents

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. PubMed 41371775 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06249776
Lead sponsor
Gravity Medical Technology, INC
Responsible party
Sponsor
First posted
Feb 8, 2024
Start date
Feb 9, 2024
Primary completion
Apr 14, 2026
Completion
Apr 14, 2026
Last update
May 22, 2026

Study contacts

Dileep R. Yavagal, MD, MBBS
study chair · University of Miami & Jackson Memorial Hospitals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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