Using a new device to remove blood clots in stroke patients

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

This study is testing a new device to see if it can safely remove blood clots from the brains of stroke patients to help them recover better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Gravity Medical Technology, INC (Industry-sponsored)
• Locations: 10 sites (New Delhi, Delhi and 9 other locations)
• Trial ID: NCT06249776 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Supernova stent retriever device developed by Gravity Medical Technology for treating acute ischemic stroke. The device is designed to remove blood clots from large vessels in the brain, restoring blood flow and potentially improving patient outcomes. Eligible participants include adults aged 18-85 who have experienced a new focal neurologic deficit due to acute cerebral ischemia and can receive treatment within 24 hours of symptom onset. The study will assess the device's performance in conjunction with standard thrombolysis treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with a new focal neurologic deficit due to acute cerebral ischemia and confirmed large vessel occlusion.

Not a fit: Patients with significant pre-stroke disability or those who do not meet the imaging criteria for large vessel occlusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could significantly improve recovery outcomes for patients suffering from acute ischemic strokes.

How similar studies have performed: Other studies have shown promise with mechanical thrombectomy devices, indicating potential for success with this novel approach.

Eligibility criteria

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.

Where this trial is running

New Delhi, Delhi and 9 other locations

• All India Institute of Medical Sciences, New Delhi — New Delhi, Delhi, India (Recruiting)
• Marengo CIMS Hospital — Ahmedabad, Gujarat, India (Recruiting)
• P.D. Hinduja Hospital and Medical Research Centre — Mumbai, Maharashtra, India (Recruiting)
• Dr Balabhai Nanavati Hospital — Mumbai, Maharashtra, India (Recruiting)
• Yashoda Hospitals, Somajiguda — Hyderabad, Telangana, India (Recruiting)
• Apollo Hospitals — Hyderabad, Telangana, India (Recruiting)
• The Calcutta Medical Research Institute — Kolkata, West Bengal, India (Recruiting)
• Jawaharlal Institute of Postgraduate Medical Education and Research — Puducherry, India (Recruiting)
• Tehran University of Medical Sciences — Tehran, Iran, Islamic Republic of (Recruiting)
• National Institute of Cardiovascular Diseases — Karachi, Sindh, Pakistan (Recruiting)

Study contacts

• Study coordinator: Shashvat M Desai, MD

Conditions Ischemic Stroke; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases