AIIMS Delhi conducts India's first dedicated clinical trial of advanced brain stent

New Delhi, Dec 13 (PTI) AIIMS Delhi has achieved a milestone in stroke care by conducting the country's first dedicated clinical trial of a cutting-edge and advanced brain stent made for treating severe strokes.

The GRASSROOT trial, which evaluated the Supernova stent (Gravity Medical Technology), has found excellent safety and efficacy outcomes in the treatment of severe strokes, officials said.

The results were published in the ‘Journal of Neurointerventional Surgery’ (JNIS), part of the prestigious British Medical Journal group.

AIIMS Delhi was the national coordinating centre and the lead enrolling site for the GRASSROOT trial – India's first clinical trial of a new and advanced stroke treatment device, the Supernova stent, the officials said.

“This trial is a turning point for stroke treatment in India,” Dr Shailesh B Gaikwad, professor and head, Department of Neuroimaging and Interventional Neuroradiology, AIIMS Delhi, and national principal investigator of the GRASSROOT trial, said.

According to the JNIS, the GRASSROOT trial evaluating the Supernova stent has found excellent safety and efficacy outcomes in the treatment of severe strokes.

Earlier this year, data from the GRASSROOT trial were accepted by the Central Drugs Standard Control Organisation (CDSCO) and the Supernova stent-retriever was approved for routine 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 said in a statement.

“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,” it said.

Noting that it produced world-class clinical evidence entirely within the country, Dr Ashutosh Jadhav, Chief Scientific Officer, Gravity Medical Technology, said the effort built a “robust framework for future large-scale, high-quality trials”.

Dr Deepti Vibha, professor of neurology, AIIMS Delhi, emphasised the role of patients and families whose participation will “bring faster, more affordable treatments to millions”.

Dr Shashvat M Desai, Chief Technology Officer at Gravity Medical Technology, described the approval 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.

Desai noted that the trial and subsequent device approval stand as a testament to the expertise of Indian leaders such as Dr Gaikwad and his team, who bring over three decades of experience in advancing stroke treatment.

Developed by Gravity Medical Technology, Supernova is designed for India's diverse patient population, where strokes often strike patients at a younger age than in the West.

“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,” Dr Dileep Yavagal, professor of neurology and neurosurgery, University of Miami, and the Global Principal Investigator of the GRASSROOT trial, said. PTI PLB ARI