AIIMS Delhi has marked a major milestone in India’s stroke care landscape by successfully leading the country’s first dedicated clinical trial of an advanced brain stent designed for patients suffering from severe stroke.
The pioneering GRASSROOT trial evaluated the Supernova stent, developed by Gravity Medical Technology, and demonstrated exceptional safety and effectiveness in removing clots and restoring blood flow. The findings have been published in the Journal of Neurointerventional Surgery (JNIS).
As the national coordinating centre and the lead enrolling site, AIIMS Delhi played a central role in driving the research. Dr Shailesh B Gaikwad, Professor and Head of Neuroimaging and Interventional Neuroradiology at AIIMS and the National Principal Investigator of the trial, called the results a significant breakthrough for India’s stroke treatment protocols. He noted that the Supernova stent showed strong performance in real-world clinical settings involving severe stroke cases.
The GRASSROOT trial spanned eight centres across India, contributing robust local clinical evidence. Based on this data, the device was submitted to the Central Drugs Standard Control Organisation (CDSCO), which subsequently approved the Supernova stent for routine use in hospitals nationwide. Importantly, this approval is grounded entirely on domestic clinical trial data—an achievement aligned with the government’s Make-in-India initiative and India’s growing strength in medical innovation.
Experts from Gravity Medical Technology praised the quality and relevance of India’s research ecosystem. Dr Ashutosh Jadhav, Chief Scientific Officer, said the study establishes a strong foundation for future large-scale trials. Dr Deepti Vibha, Professor of Neurology at AIIMS Delhi, highlighted the invaluable contribution of patients and families in making high-end stroke treatments more accessible and affordable.
Dr Shashvat M Desai, Chief Technology Officer at Gravity Medical Technology, added that the approval reflects India’s ability to conduct globally competitive trials. The Supernova stent is tailored to India’s unique stroke profile, where strokes tend to occur at a younger age compared to Western populations. The device has already been used to treat more than 300 patients in Southeast Asia, reinforcing its safety and versatility.
Global Principal Investigator Dr Dileep Yavagal, Professor of Neurology and Neurosurgery at the University of Miami, said the stent will now be manufactured in India at affordable prices, offering new hope to the 1.7 million Indians who suffer a stroke every year.
