In a landmark development, AIIMS New Delhi led India’s first successful clinical trial of an indigenously tested advanced stroke device, demonstrating that high-quality, effective, and affordable stroke treatment can be delivered entirely within the country.
GRASSROOT Trial Evaluates Supernova Stent Retriever
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, tested the Supernova stent retriever, a device designed to remove clots in patients experiencing severe strokes caused by large vessel blockages. The trial’s results, published in the Journal of Neurointerventional Surgery (BMJ Group), indicate outcomes comparable with the best international standards.
Multicentre Trial Across India
The multicentre trial enrolled 32 patients across eight stroke centres in India between August 2024 and June 2025. The first patient was recruited on August 26, 2024, and the last on June 15, 2025. Patients had an average age of 58 years, with nearly one-third being women. Many participants had comorbidities such as hypertension, diabetes, or heart disease. Most patients reached the hospital within a median of just over 6 hours from stroke onset. Blockages were primarily located in major brain arteries, particularly the middle cerebral artery.
High Success Rates and Positive Outcomes
The trial demonstrated that clinicians successfully restored blood flow in nearly 94% of patients, often within one or two attempts without additional rescue therapy. At 90 days, half of the patients regained functional independence. Mortality and severe brain bleeding were low, and no device-related complications were reported. Stroke severity scores steadily improved from admission to discharge and at three-month follow-up.
Implications for Stroke Care in India
Dr. Shailesh B. Gaikwad, Professor and Head of Neuroimaging and Interventional Neuroradiology at AIIMS and national principal investigator of the trial, called the findings a turning point. He emphasised that India can now generate world-class clinical evidence for advanced stroke treatment without relying solely on imported devices. Experts highlight that speed and reliability are critical in stroke care, and a device that reopens blocked vessels efficiently improves survival and reduces long-term disability—especially in resource-limited settings.
Regulatory Approval and Make-in-India Boost
Based on the trial data, the Central Drugs Standard Control Organisation (CDSCO) approved the Supernova stent for routine use, marking India’s first stroke device cleared entirely on the basis of a domestic clinical trial. This approval strengthens the Make-in-India initiative and expands access to advanced stroke therapy across the country.
Collaborative Efforts Driving Affordable Stroke Treatment
Dr. Deepti Vibha, Professor of Neurology at AIIMS, noted that patient participation will help bring faster and more affordable stroke therapies to millions of Indians. Dr. Ashutosh Jadhav, Chief Scientific Officer of Gravity Medical Technology, said the trial lays a strong foundation for future large-scale, India-led clinical research.
Dr. Dileep Yavagal, Global Principal Investigator of the trial, highlighted that the Supernova device has already treated over 300 patients in Southeast Asia and that manufacturers will now produce it in India at affordable prices—a crucial development in a country where nearly 1.7 million people suffer a stroke each year.
This achievement positions India as a global leader in domestic innovation for life-saving stroke interventions while ensuring accessibility and affordability for patients nationwide.