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AIIMS Delhi Leads India’s First Clinical Trial of Advanced Brain Stent

Medical Technology

GRASSROOT Trial Validates Supernova Stroke StentRx

Business Honor
15 December, 2025

GRASSROOT trial proves safety, efficacy of Supernova stent for severe stroke treatment

AIIMS Delhi has achieved a major medical landmark by successfully conducting India's first dedicated clinical trial of an advanced brain stent that treats severe strokes. A study, popularly known as the GRASSROOT trial, was conducted on the Supernova stent developed by Gravity Medical Technology and showed excellent safety and effectiveness. Results of the trial have been published in the Journal of Neurointerventional Surgery, part of the British Medical Journal group, underlining the research's universal value. AIIMS Delhi was the national coordinating center and the lead enrolling site, which means this is the first time that India has been able to test a next-generation stroke treatment device itself with a domestic clinical trial.

According to officials, the Supernova stent performed strongly in patients with life-threatening strokes. Earlier this year, data from the GRASSROOT trial were accepted by the Central Drugs Standard Control Organization, paving the way for regulatory approval of the device for routine clinical use in India. This makes Supernova the first stroke device in the country to receive clearance based entirely on Indian clinical evidence. Conducted across eight medical centers, the trial aligns with the Make-in-India initiative and highlights India's growing capability in advanced medical research and device development. Experts involved in the study said the trial establishes a strong framework for future large-scale and high-quality clinical research within the country.

The Supernova stent, developed specifically for India's diverse patient population, addresses the problem of strokes happening at a younger age in the country compared to Western nations. Already used in the treatment of over 300 patients in Southeast Asia, the device will now be manufactured in India, ensuring availability at affordable prices. With nearly 1.7 million Indians suffer from strokes each year, the successful completion of the GRASSROOTS trial constitutes a major step toward better access to advanced, life-saving stroke care throughout the country.