AIIMS Delhi Conducts India’s First Dedicated Clinical Trial of Advanced Brain Stent

India has created a medical history by conducting the country’s first-ever dedicated clinical trial of an advanced brain stent for severe stroke treatment at AIIMS Delhi. The trial, known as the GRASSROOT trial, was conducted to assess an indigenously developed medical device called the Supernova stent manufactured by Gravity Medical Technology. This success story assumes relevance both in public health and medical research, considering the prevalence of stroke conditions among about 1.7 million people in the country every year.

What Is the GRASSROOT Trial?

• Type: India’s first domestic, multi-centre clinical trial focused on a stroke intervention device
• Lead Institution: AIIMS Delhi
• Coverage: 8 medical centres across India
• Objective: Evaluate safety and efficacy of the Supernova stent in large vessel occlusion strokes

Outcome

• Reported excellent safety and clinical outcomes
• Results published in the Journal of Neurointerventional Surgery (BMJ Group)

Significance

• Demonstrates India’s capacity to generate globally credible clinical evidence
• Reduces dependence on foreign trials for regulatory approvals

What Is the Supernova Stent?

• Device Type: Stent-retriever used in mechanical thrombectomy
• Function: Physically removes blood clots from blocked brain arteries

India-specific design considerations:

• Younger age of stroke onset
• Anatomical and lifestyle differences compared to Western populations

Clinical experience

• Successfully used in 300+ patients across Southeast Asia

Objectives of the Trial

The main objective of the GRASSROOT trial was to assess whether the Supernova stent is safe and effective for Indian stroke patients.

Another key aim was to generate high-quality clinical evidence within India, reducing dependence on foreign trials and supporting regulatory decisions based on Indian patient data.

Regulatory Approval

• First-ever stroke device in India approved solely on domestic clinical trial data

Signals,

• Strengthening of India’s medical device regulatory ecosystem
• Growing trust in Indian clinical research standards
• Sets a precedent for future indigenous device approvals

Institutional and Leadership Role

• AIIMS Delhi: National Principal Investigator Dr Shailesh B. Gaikwad & Highlighted as a turning point in neurointerventional care
• Clinical leadership: Contribution of neurologists, neuroradiologists, and patient volunteers
• Industry–academia collaboration: Gravity Medical Technology enabled translation from research to practice
• Global collaboration: International expertise enhanced trial quality while retaining Indian leadership

Linkages with Government Initiatives

• Make in India: Indigenous design, manufacturing, and approval
• Atmanirbhar Bharat: Reduced import dependence in critical medical devices
• National Health Policy 2017: Emphasis on affordable and accessible tertiary care
• Ayushman Bharat–PMJAY (indirect relevance): Lower device costs can enhance coverage of advanced procedures

Key Takeaways

• AIIMS Delhi conducted India’s first dedicated clinical trial of an advanced brain stent.
• The GRASSROOT trial evaluated the Supernova stent developed by Gravity Medical Technology.
• The trial showed excellent safety and efficacy in treating severe strokes.
• Results were published in a BMJ group journal.
• CDSCO approval was granted based on domestic clinical trial data.