AIIMS Delhi Marks Milestone With India’s First Dedicated Brain Stent Trial for Stroke Care

AIIMS Delhi has marked a major milestone in India’s stroke care ecosystem by conducting the country’s first dedicated clinical trial of an advanced brain stent for severe strokes. The trial, known as GRASSROOT, evaluated the Supernova stent developed by Gravity Medical Technology and demonstrated strong safety and efficacy outcomes. The achievement positions India among a select group of countries capable of independently generating high-quality clinical evidence for advanced neurointerventional devices.

India’s First Domestic Stroke Device Trial

The GRASSROOT trial represents the first time a novel stroke treatment device has been clinically tested, validated, and approved in India based entirely on domestic data. AIIMS Delhi served as the national coordinating centre and the lead enrolling site. Conducted across eight centres, the trial focused on patients with life-threatening large vessel occlusion strokes, a condition requiring rapid and precise intervention to reduce disability and mortality.

Clinical Results and Regulatory Approval

Findings from the GRASSROOT trial showed excellent safety and efficacy of the Supernova stent in restoring blood flow during severe strokes. The results were published in the Journal of Neurointerventional Surgery, part of the British Medical Journal group. Based on these outcomes, the Central Drugs Standard Control Organisation approved the Supernova stent-retriever for routine clinical use in India, making it the nation’s first stroke device cleared through a home-grown clinical trial.

Innovation Tailored for Indian Patients

The Supernova stent has been specifically designed to address India’s stroke burden, where patients often experience strokes at a younger age compared to Western populations. Developed under the Make-in-India initiative, the device has already been used to treat more than 300 patients across Southeast Asia. With domestic manufacturing now planned, the stent is expected to be available at more affordable costs, expanding access to advanced stroke care for Indian patients.

Exam Oriented Facts

• AIIMS Delhi coordinated India’s first clinical trial of an indigenous stroke device.
• The GRASSROOT trial results were published in the Journal of Neurointerventional Surgery.
• CDSCO approved the Supernova stent based on domestic clinical data.
• India reports an estimated 1.7 million stroke cases annually.

Implications for India’s Medical Research Landscape

Experts have described the GRASSROOT trial as a turning point for Indian medical innovation. It demonstrates that India can design, execute, and regulate clinical trials of global standards. The success of the Supernova stent trial is expected to strengthen confidence in Indian research capabilities, accelerate access to life-saving therapies, and encourage further development of advanced medical devices within the country.