In a major advancement for stroke care in the country, AIIMS Delhi has successfully carried out India’s first exclusive clinical trial of an advanced brain stent developed for the management of severe strokes.
Known as the GRASSROOT trial, the study assessed the Supernova stent-retriever developed by Gravity Medical Technology and demonstrated strong safety and effectiveness outcomes in patients with severe stroke conditions, according to officials.
The findings of the trial have been published in the Journal of Neurointerventional Surgery (JNIS), a reputed publication under the British Medical Journal (BMJ) group.
AIIMS Delhi served as both the national coordinating centre and the leading enrolment site for the GRASSROOT trial, making it the country’s first clinical evaluation of a next-generation stroke treatment device of this kind.
“This trial is a turning point for stroke treatment in India,” said Dr Shailesh B Gaikwad, Professor and Head of the Department of Neuroimaging and Interventional Neuroradiology at AIIMS Delhi, who also served as the national principal investigator for the trial.
As reported by JNIS, the GRASSROOT trial confirmed excellent safety and efficacy results for the Supernova stent in treating severe stroke cases.
Earlier this year, the clinical data generated from the GRASSROOT trial received acceptance from the Central Drugs Standard Control Organisation (CDSCO), leading to regulatory approval of the Supernova stent-retriever for routine clinical use in India.
“This is the nation’s first stroke device cleared based on a domestic clinical trial. The approval follows the GRASSROOT India trial, which confirmed the device’s safety and efficacy in treating life-threatening strokes,” AIIMS stated.
“Conducted across eight centres, the trial marks a milestone for the Make-in-India initiative and positions India as a global player in advanced stroke care,” the statement added.
Highlighting the broader impact of the study, Dr Ashutosh Jadhav, Chief Scientific Officer at Gravity Medical Technology, noted that the trial generated world-class clinical evidence entirely within India and helped establish a “robust framework for future large-scale, high-quality trials”.
Dr Deepti Vibha, Professor of Neurology at AIIMS Delhi, acknowledged the critical role played by patients and their families, stating that their participation will “bring faster, more affordable treatments to millions”.
Calling the approval a landmark achievement, Dr Shashvat M Desai, Chief Technology Officer at Gravity Medical Technology, described it as “more than just a regulatory milestone”.
“This achievement demonstrates that India can design and deliver clinical trials of global significance, accelerating access to advanced therapies while upholding equity,” he said.
Dr Desai further credited Indian clinical leadership, including Dr Gaikwad and his team, whose combined experience of over three decades has been instrumental in advancing stroke care in the country.
Developed specifically with India’s patient demographics in mind—where strokes often occur at a younger age compared to Western populations—the Supernova stent has already been used to treat more than 300 patients across Southeast Asia.
“The device has already treated more than 300 patients in Southeast Asia. It will now be manufactured and made available in India at affordable prices, offering new hope to the 1.7 million Indians who suffer strokes each year,” said Dr Dileep Yavagal, Professor of Neurology and Neurosurgery at the University of Miami and Global Principal Investigator of the GRASSROOT trial.
(Image for representational purpose only)