New Delhi

In a major breakthrough for stroke treatment in India, AIIMS Delhi has successfully conducted the country’s first dedicated clinical trial of an advanced brain stent, marking a significant milestone in indigenous medical innovation.

The clinical study, known as the GRASSROOT trial, evaluated the Supernova stent, developed by Gravity Medical Technology, and demonstrated excellent safety and efficacy in the treatment of severe, life-threatening strokes, officials said.

The findings of the trial have been published in the Journal of Neurointerventional Surgery (JNIS), a peer-reviewed publication under the British Medical Journal (BMJ) group, lending global credibility to the research.

AIIMS Delhi served as the national coordinating centre and the lead enrolling site for the GRASSROOT trial, making it the first institution in the country to lead a full-scale clinical evaluation of an advanced stroke device designed and tested within India.

Calling the achievement transformative, 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 a turning point for stroke care in the country.

Earlier this year, data generated 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 described this as the first stroke treatment device in the country to receive regulatory clearance based entirely on a domestic clinical trial, underscoring the growing strength of India’s medical research ecosystem.

Conducted across eight medical centres, the trial aligns with the Make-in-India initiative and positions India as an emerging global contributor to advanced neuro-interventional care.

Dr Ashutosh Jadhav, Chief Scientific Officer of Gravity Medical Technology, said the trial generated world-class clinical evidence within India and laid the foundation for future large-scale, high-quality medical trials.

Highlighting the human element behind the research, Dr Deepti Vibha, Professor of Neurology at AIIMS Delhi, acknowledged the vital role played by patients and their families, noting that their participation will help ensure faster and more affordable treatments for millions.

Describing the approval as more than a regulatory achievement, Dr Shashvat M. Desai, Chief Technology Officer at Gravity Medical Technology, said it demonstrated India’s ability to design and execute clinical trials of international significance while ensuring equitable access to advanced therapies.

Developed specifically with Indian patients in mind—where strokes often occur at a younger age—the Supernova stent has already been used to treat over 300 patients across Southeast Asia.

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Dr Dileep Yavagal, Professor of Neurology and Neurosurgery at the University of Miami and Global Principal Investigator of the GRASSROOT trial, said the device will now be manufactured and made available in India at affordable prices, offering renewed hope to the 1.7 million Indians affected by stroke every year.