New Delhi : AIIMS New Delhi has led India’s first successful clinical trial of an indigenously tested advanced stroke device, a development that could significantly improve access to timely and affordable stroke care, a TOI report stated. The trial demonstrated that high-quality treatment for severe strokes can be delivered within the country, with outcomes comparable to global standards.
The Gravity Stent-Retriever System for Reperfusion of Large Vessel Occlusion Stroke Trial (GRASSROOT), with AIIMS New Delhi as the national coordinating centre and lead enrolling site, evaluated the Supernova stent retriever used to remove clots in patients suffering from severe strokes caused by large vessel blockages. The results were published this month in the Journal of Neurointerventional Surgery, a BMJ group journal.
The multicentre trial enrolled 32 patients across eight stroke centres in India between August 2024 and June 2025. The average age of patients was 58 years, with nearly one-third women. Many participants had risk factors such as hypertension, diabetes and heart disease. Most reached hospitals within a critical window, with a median arrival time of just over six hours after stroke onset. Blockages were largely found in major brain arteries, particularly the middle cerebral artery.
Calling the findings a turning point, Dr Shailesh B. Gaikwad, professor and head of neuroimaging and interventional neuroradiology at AIIMS and national principal investigator of the trial, told TOI that the study shows India can generate world-class clinical evidence for advanced stroke treatment instead of depending entirely on imported devices.
Doctors were able to restore blood flow to the brain in nearly 94% of patients, often within one or two attempts and without the need for additional rescue therapy. By 90 days, about half of the patients had regained functional independence. Mortality and serious brain bleeding rates were low, and no device-related complications were reported. Stroke severity scores showed steady improvement from admission to discharge and at three-month follow-up.
Experts said the results are significant because speed and reliability are critical in stroke care. Devices that can reopen blocked vessels quickly, ideally on the first attempt, improve survival and reduce long-term disability, especially in resource-limited settings.
Earlier this year, based on the trial data, the Central Drugs Standard Control Organisation approved the Supernova stent for routine use, making it India’s first stroke device to be cleared entirely on the basis of a domestic clinical trial. The approval is being seen as a boost for the Make-in-India initiative and for widening access to advanced stroke treatment.
Dr Deepti Vibha, professor of neurology at AIIMS, told TOI that participation from patients and their families will help bring faster and more affordable stroke therapies to millions. Gravity Medical Technology’s chief scientific officer, Dr Ashutosh Jadhav, told TOI that the trial has laid a strong foundation for future large-scale, India-led clinical research. Welcoming the development, Dr Dileep Yavagal, global principal investigator of the trial, told TOI that the Supernova device has already been used in more than 300 patients across Southeast Asia and will now be manufactured in India at affordable prices, a critical factor in a country where nearly 1.7 million people suffer a stroke every year.
