AIIMS New Delhi achieved a significant milestone by successfully leading India’s first dedicated, multi-centre clinical trial of an advanced, indigenously tested stroke device.
📝 Key Trial Information
| Aspect | Detail |
| Lead Institution | All India Institute of Medical Sciences (AIIMS), New Delhi (National Coordinating Centre and Lead Enrolling Site). |
| Trial Name | GRASSROOT (Gravity Stent-Retriever System for Reperfusion of Large Vessel Occlusion Stroke Trial). |
| Device Name | Supernova Stent-Retriever (Advanced Brain Stent). |
| Developer | Gravity Medical Technology (Indian medical technology company). |
| Target Condition | Severe Stroke caused by Large Vessel Occlusion (LVO) in the brain, requiring rapid clot removal (mechanical thrombectomy). |
| Trial Scope | Multicentre trial across eight stroke centres in India (August 2024 to June 2025). |
| Publication | Results published in the Journal of Neurointerventional Surgery (JNIS) (BMJ Group). |
🛠️ The Supernova Stent-Retriever
The device is a stent-retriever, a cylindrical mesh tube used in a procedure called mechanical thrombectomy.
- Function: It is inserted via a catheter, expanded within the blocked artery to trap the blood clot, and then pulled out with the clot, rapidly restoring blood flow to the brain.
- Design Rationale: Specifically designed for the Indian patient population, where strokes often occur at a younger age and arteries may have anatomical differences compared to Western populations.
📈 Major Outcomes and Significance
- Efficacy: Blood flow was successfully restored in nearly 94% of patients, often within one or two attempts.
- Functional Recovery: Approximately 50% of patients regained functional independence by the 90-day follow-up.
- Safety: Low rates of mortality and serious brain bleeding; no device-related complications reported.
- Regulatory Milestone: Based on the successful trial data, the Central Drugs Standard Control Organisation (CDSCO) approved the Supernova stent for routine use. This is the first stroke device in India to be cleared based entirely on a domestic clinical trial.
- “Make-in-India” Boost: The device will now be manufactured in India and is expected to be available at a significantly more affordable price than imported devices, expanding access to life-saving care for millions of Indians who suffer strokes annually.