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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 .

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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).

• 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.

Locations
Other Locations
India
Marengo CIMS Hospital
RECRUITING
Ahmedabad
Apollo Hospitals
RECRUITING
Hyderabad
Yashoda Hospitals, Somajiguda
RECRUITING
Hyderabad
The Calcutta Medical Research Institute
RECRUITING
Kolkata
Dr Balabhai Nanavati Hospital
RECRUITING
Mumbai
P.D. Hinduja Hospital and Medical Research Centre
RECRUITING
Mumbai
All India Institute of Medical Sciences, New Delhi
RECRUITING
New Delhi
Jawaharlal Institute of Postgraduate Medical Education and Research
RECRUITING
Puducherry
Islamic Republic of Iran
Tehran University of Medical Sciences
RECRUITING
Tehran
Pakistan
National Institute of Cardiovascular Diseases
RECRUITING
Karachi
Contact Information
Primary
Shashvat M Desai, MD
shashvat.desai@gravitymedtech.com
4122188258
Backup
Yuvateja Thotamalla
yuvateja.tho@gravitymedtech.com
7330868999
Time Frame
Start Date: 2024-02-09
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 100
Treatments
Experimental: Supernova revascularization device
Mechanical thrombectomy with Supernova Stent Retriever
Related Therapeutic Areas
Sponsors
Leads: Gravity Medical Technology, INC

This content was sourced from clinicaltrials.gov