New Delhi: AIIMS New Delhi has completed India's first clinical trial of an indigenously tested brain stent for treating severe strokes, marking a milestone in the country's stroke care capabilities. The results, published this month in the Journal of NeuroInterventional Surgery, demonstrate that high-quality, affordable stroke treatment can be delivered within India.

The GRASSROOT trial evaluated the Supernova stent retriever, a device designed to remove blood clots in patients suffering from acute ischemic strokes caused by large vessel blockages. The multicentre trial enrolled 32 patients across eight stroke centres between August 2024 and June 2025, with the first patient recruited on August 26 last year.

Strong Safety and Efficacy Results

According to the published findings, doctors were able to restore blood flow to the brain in nearly 94% of patients, often within one or two attempts without additional rescue therapy. By 90 days, half of the patients regained functional independence, while mortality and serious brain bleeding remained low with no device-related complications reported.

The average age of patients was 58 years, and nearly one-third were women. Many had existing risk factors such as hypertension, diabetes and heart disease, with most reaching the hospital within a median time of just over six hours after stroke onset.

"This trial is a turning point for stroke treatment in India," said Dr Shailesh B. Gaikwad, professor and head of neuroimaging and interventional neuroradiology at AIIMS and national principal investigator of the trial.

Regulatory Approval and Manufacturing Plans

Based on the trial data, the Central Drugs Standard Control Organisation approved the Supernova stent for routine use earlier this year, making it India's first stroke device cleared entirely based on a domestic clinical trial. The approval represents a boost for the Make-in-India initiative in advanced medical devices.

Developed by Gravity Medical Technology, the Supernova device is specifically designed for India's patient population, where strokes often occur at younger ages than in Western countries. According to Dr Dileep Yavagal, global principal investigator of the trial and professor at the University of Miami, the device has already treated more than 300 patients in Southeast Asia and will now be manufactured in India at affordable prices.

The development is particularly significant given that approximately 1.7 million Indians suffer strokes annually, yet only about 4,500 patients currently receive mechanical thrombectomy treatment each year.