Ischemic StrokeGRASSROOTNCT06249776
Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial
A study testing Supernova revascularization device in people with Ischemic Stroke and Stroke, run by Gravity Medical Technology, INC at 11 sites in 3 countries.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke, Stroke, Cerebrovascular Disorders
- What is being tested?
- Supernova revascularization device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 9 Feb 2024to 14 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New focal neurologic deficit consistent with being of acute cerebral ischemia origin.
- Age 18-85 years old (inclusive).
- Interventionalists estimate that treatment with the Supernova (first deployment in target vessel) can be achieved within 24 hours of symptom onset.
- 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.
- Admission NIH Stroke Scale score of 8-25
- No known significant pre-stroke disability (pre-stroke mRS 0 or 1).
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- 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.
- For strokes in the anterior circulation, the following imaging criteria should also be met:
- MRI criterion: volume of diffusion restriction visually assessed ≤50 mL, OR
- CT criterion: ASPECTS 6 to 10 on baseline NCCT
- Anticipated life expectancy of at least 6 months.
- A signed informed consent by the patient or a Legally Authorized Representative or independent physician in case of oral consent.
Who cannot join
- Subject already participating in another study of an investigational treatment device or treatment.
- Use any other intra-arterial recanalization drug or device prior to the use of Supernova (Supernova is not the first-choice device).
- Angiographically evident excessive arterial tortuosity precluding device access to the thrombus.
- 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.
- Glucose < 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L).
- Known hemorrhagic diathesis.
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- Coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 3.0.
- Treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal.
- 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.
- Platelet count of less than 50,000/ µL.
- History of severe allergy to contrast medium, nickel, or Nitinol.
- Intracranial hemorrhage.
- Significant mass effect with midline shift.
- Intracranial tumor (apart from small meningioma, ≤ 2 cm in diameter).
- 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).
- Presence of intracranial atherosclerotic disease requiring rescue therapy (for example, intracranial stenting).
- Females who are pregnant or breastfeeding.
- Known current use of narcotic drugs at the time of treatment.
- Prior recent stroke in the past 3 months.
- Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30.
- Known cerebral vasculitis.
- 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.
- Clinical symptoms are suggestive of bilateral stroke or stroke in multiple territories.
- Ongoing seizure due to stroke.
- Evidence of active systemic infection.
- Known cancer with metastases.
- Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
- Evidence of dissection in the extra or intracranial cerebral arteries.
- Occlusions in multiple vascular territories (e.g., bilateral anterior circulation or anterior/posterior circulation).
- Aneurysm in the target vessel.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
India9 sites
Marengo CIMS Hospital
Ahmedabad, Gujarat, 380060
Yashoda Hospitals, Secunderabad
Hyderabad, Telangana, 500082
Yashoda Hospitals, Somajiguda
Hyderabad, Telangana, 500082
Apollo Hospitals
Hyderabad, Telangana, 500096
The Calcutta Medical Research Institute
Kolkata, West Bengal, 700027
P.D. Hinduja Hospital and Medical Research Centre
Mumbai, Maharashtra, 400016
Dr Balabhai Nanavati Hospital
Mumbai, Maharashtra, 400056
All India Institute of Medical Sciences, New Delhi
New Delhi, National Capital Territory of Delhi, 110029
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, Puducherry, 605006
Iran1 site
Tehran University of Medical Sciences
Tehran, Tehran Province, 1416753955
Pakistan1 site
National Institute of Cardiovascular Diseases
Karachi, Sindh, 75510
About this study
Official title: 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 .
- Conditions
- Ischemic Stroke, Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Being tested
- Supernova revascularization device
- Keywords
- Mechanical thrombectomy, Brain, Brain clot, Brain infarction, Cerebral ischemia, Neurovascular intervention, Revascularization, Reperfusion, Stent retriever, Supernova, Stroke, Gravity Medical Technology
- Medical subject headings
- Ischemic Stroke, Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supernova revascularization deviceDevice
Mechanical Thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Supernova revascularization device | Experimental | Mechanical thrombectomy with Supernova Stent Retriever Receives: Device: Supernova revascularization device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: sICH measured within 24 (18-36) hours of the study procedure
All-cause mortality
Safety (All-cause mortality)
Measured: All-cause mortality measured at 90 (±14) days
Secondary outcomes (4)
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)
Measured: 90 (±14) days post-treatment
Successful Reperfusion at First Pass
Effectiveness (Successful reperfusion defined as mTICI 2b or better at first pass)
Measured: Assessed at first pass of the intervention during the procedure
Asymptomatic Intracranial Hemorrhage
Safety (Incidence of any asymptomatic intracranial hemorrhage post-procedure)
Measured: 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)
Measured: Day 1 (within 24 hours (18-36 hours) of the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start9 Feb 2024
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gravity Medical Technology, INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dileep R. Yavagal, MD, MBBS, Study chair, University of Miami & Jackson Memorial Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249776
- Sponsor's protocol ID
- GMT-GRASSROOT-24-01
- Acronym
- GRASSROOT
- Status last verified
- May 2026
- First submitted
- 25 Jan 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial (GRASSROOT)
- ClinicalTrials.gov ID
- NCT06249776
- Acronym / sponsor ID
- GRASSROOT / GMT-GRASSROOT-24-01
- Conditions
- Ischemic Stroke, Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Keywords
- Mechanical thrombectomy, Brain, Brain clot, Brain infarction, Cerebral ischemia, Neurovascular intervention, Revascularization, Reperfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Gravity Medical Technology, INCIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supernova revascularization device | Experimental | Device: Supernova revascularization deviceMechanical thrombectomy with Supernova Stent Retriever |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- New focal neurologic deficit consistent with being of acute cerebral ischemia origin.
- Age 18-85 years old (inclusive).
- Interventionalists estimate that treatment with the Supernova (first deployment in target vessel) can be achieved within 24 hours of symptom onset.
- 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.
- Admission NIH Stroke Scale score of 8-25
Key exclusion criteria (30 listed)
- Subject already participating in another study of an investigational treatment device or treatment.
- Use any other intra-arterial recanalization drug or device prior to the use of Supernova (Supernova is not the first-choice device).
- Angiographically evident excessive arterial tortuosity precluding device access to the thrombus.
- 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.
- Glucose < 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supernova revascularization deviceMechanical Thrombectomy | Device | Supernova revascularization device |
Primary outcome
Successful reperfusion
Time frame: Day 0 (end of procedure)
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
Symptomatic intracranial hemorrhage
Time frame: sICH measured within 24 (18-36) hours of the study procedure
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.
All-cause mortality
Time frame: All-cause mortality measured at 90 (±14) days
Safety (All-cause mortality)
4 secondary outcomes
Percentage of participants with a modified Rankin Scale (mRS) score of ≤2
Time frame: 90 (±14) days post-treatment
Successful Reperfusion at First Pass
Time frame: Assessed at first pass of the intervention during the procedure
Asymptomatic Intracranial Hemorrhage
Time frame: Day 1 (within 24 hours (18-36 hours) of the procedure)
Neurological Deterioration
Time frame: Day 1 (within 24 hours (18-36 hours) of the procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 41371775Yavagal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dileep R. Yavagal, MD, MBBS study chair
University of Miami & Jackson Memorial Hospitals
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supernova revascularization device in people with Ischemic Stroke and Stroke, run by Gravity Medical Technology, INC at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India, Iran, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful reperfusion (time frame: Day 0 (end of procedure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06249776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.