AIIMS New Delhi has successfully conducted India’s first clinical trial of an indigenously developed advanced stroke device, demonstrating outcomes that match global standards and could significantly improve access to affordable stroke care nationwide.
The Gravity Stent-Retriever System for Reperfusion of Large Vessel Occlusion Stroke Trial (GRASSROOT), with AIIMS as the national coordinating centre and lead enrolling site, evaluated the Supernova stent retriever—a device used to remove clots in patients suffering from severe strokes caused by large vessel blockages.
Results of the multicentre trial, published this month in the Journal of Neurointerventional Surgery, a BMJ group journal, show that high-quality treatment for severe strokes can be delivered within the country at par with international benchmarks.
The trial enrolled 32 patients across eight stroke centres in India between August 2024 and June 2025. Participants had an average age of 58 years, with nearly one-third women, and many had risk factors such as hypertension, diabetes and heart disease. Most patients reached hospitals within a critical window, with a median arrival time of just over six hours after stroke onset, and blockages were most frequently found in major brain arteries like the middle cerebral artery.
Doctors were able to restore blood flow to the brain in nearly 94% of patients, often within one or two attempts and without additional rescue therapy, while mortality and serious brain bleeding rates were low and no device-related complications were reported. Around half of patients regained functional independence by 90 days, and stroke severity scores showed steady improvement from admission through to the three-month follow-up.
Earlier this year, based on GRASSROOT trial data, the Central Drugs Standard Control Organisation approved the Supernova stent for routine use in India, making it the first stroke device to be cleared entirely on the basis of a domestic clinical trial.
This approval is being seen as a boost to the Make-in-India initiative and efforts to widen access to advanced stroke treatment. 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 crucial development in a country where nearly 1.7 million people suffer strokes every year.
