AIIMS Delhi has conducted India’s first dedicated clinical trial of an advanced brain stent for the treatment of severe strokes, marking a significant development in stroke care.
The trial, named GRASSROOT, evaluated the Supernova stent developed by Gravity Medical Technology. According to officials, the study demonstrated favourable safety and efficacy outcomes in patients with severe strokes. The findings have been published in the Journal of NeuroInterventional Surgery (JNIS), a publication of the British Medical Journal (BMJ) Group.
AIIMS Delhi served as the national coordinating centre and the lead enrolling site for the GRASSROOT trial, which is the country’s first clinical trial of a new stroke treatment device conducted entirely in India.
Dr Shailesh B Gaikwad, Professor and Head of the Department of Neuroimaging and Interventional Neuroradiology at AIIMS Delhi and the national principal investigator of the trial, said the study represents an important step in the advancement of stroke treatment in the country.
Earlier this year, data from the GRASSROOT trial were accepted by the Central Drugs Standard Control Organisation (CDSCO), leading to the approval of the Supernova stent-retriever for routine clinical use in India. AIIMS stated that this is the first stroke device in the country to receive regulatory clearance based on evidence generated through a domestic clinical trial.
The multi-centre trial was conducted across eight institutions and is seen as a milestone for the Make-in-India initiative in medical devices. Officials noted that the study demonstrated India’s ability to generate high-quality clinical evidence for advanced healthcare technologies.
Dr Ashutosh Jadhav, Chief Scientific Officer at Gravity Medical Technology, said the trial established a framework for conducting large-scale, high-quality clinical studies within the country. Dr Deepti Vibha, Professor of Neurology at AIIMS Delhi, highlighted the contribution of patients and their families, noting that such participation can help enable wider access to effective and affordable treatments.
Dr Shashvat M Desai, Chief Technology Officer at Gravity Medical Technology, said the approval reflects the growing capacity of Indian institutions to conduct clinically significant research. He also acknowledged the role of the AIIMS Delhi team in leading the trial.
Developed by Gravity Medical Technology, the Supernova stent has been designed keeping in mind the clinical characteristics of stroke patients in India, where strokes often occur at a younger age compared to Western populations. According to the developers, the device has already been used in more than 300 patients across Southeast Asia.
Following regulatory approval, the Supernova stent is expected to be manufactured and made available in India, with the aim of improving access to advanced stroke treatment for a large number of patients nationwide.
