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

NCT06249776 | Recruiting DMC

• 1 other identifier: GMT-GRASSROOT-24-01
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 11

Brief 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 .

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Percentage of participants with a modified Rankin Scale (mRS) score of ≤2

  90 (±14) days post-treatment

• Successful Reperfusion at First Pass

  Assessed at first pass of the intervention during the procedure

• Asymptomatic Intracranial Hemorrhage

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

• Neurological Deterioration

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

Study Arms (1)

Supernova revascularization device

EXPERIMENTAL

Mechanical thrombectomy with Supernova Stent Retriever

Device: Supernova revascularization device

Interventions

Supernova revascularization device DEVICE

Mechanical Thrombectomy

Supernova revascularization device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Admission NIH Stroke Scale score of 8-25
• No known significant pre-stroke disability (pre-stroke mRS 0 or 1).
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Gravity Medical Technology, INC: lead

Study Sites (11)

Marengo CIMS Hospital

Ahmedabad, Gujarat, 380060, India

RECRUITING

P.D. Hinduja Hospital and Medical Research Centre

Mumbai, Maharashtra, 400016, India

RECRUITING

Dr Balabhai Nanavati Hospital

Mumbai, Maharashtra, 400056, India

RECRUITING

All India Institute of Medical Sciences, New Delhi

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, Puducherry, 605006, India

RECRUITING

Yashoda Hospitals, Secunderabad

Hyderabad, Telangana, 500082, India

RECRUITING

Yashoda Hospitals, Somajiguda

Hyderabad, Telangana, 500082, India

RECRUITING

Apollo Hospitals

Hyderabad, Telangana, 500096, India

RECRUITING

The Calcutta Medical Research Institute

Kolkata, West Bengal, 700027, India

RECRUITING

Tehran University of Medical Sciences

Tehran, Tehran Province, 1416753955, Iran

RECRUITING

National Institute of Cardiovascular Diseases

Karachi, Sindh, 75510, Pakistan

RECRUITING

Related Publications (1)

• 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.

  PMID: 41371775 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Dileep R. Yavagal, MD, MBBS

  University of Miami & Jackson Memorial Hospitals

  STUDY CHAIR

Central Study Contacts

Shashvat M Desai, MD

CONTACT

4122188258; shashvat.desai@gravitymedtech.com

Yuvateja Thotamalla

CONTACT

7330868999; yuvateja.tho@gravitymedtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 8, 2024
• Study Start: February 9, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1); IR (1); IN (9)