India has made significant strides in medical research by conducting the first-ever dedicated clinical trial of an advanced brain stent for severe stroke treatment at AIIMS Delhi. This trial, known as the GRASSROOT trial, aimed to evaluate an indigenously developed medical device called the Supernova stent, manufactured by Gravity Medical Technology. This achievement is particularly relevant given that approximately 1.7 million people in India suffer from strokes each year.
The GRASSROOT trial not only showcases India’s ability to generate credible clinical evidence but also reduces reliance on foreign trials for regulatory approvals. This advancement enhances the credibility of Indian medical research on a global scale.
The primary goal of the GRASSROOT trial was to determine the safety and effectiveness of the Supernova stent for stroke patients in India. Additionally, the trial aimed to produce high-quality clinical evidence locally, thereby supporting regulatory decisions based on Indian patient data.
This was the first stroke device in India approved solely on data from domestic clinical trials. This marks a strengthening of India’s medical device regulatory ecosystem and builds trust in local clinical research standards, setting a precedent for future indigenous device approvals.
AIIMS Delhi served as the national principal investigator, with Dr. Shailesh B. Gaikwad leading the initiative, marking a crucial turning point in neurointerventional care. The collaboration among neurologists, neuroradiologists, and patient volunteers was vital for the trial's success. Additionally, the partnership with Gravity Medical Technology facilitated the transition from research to practical application.
Q1. What is the GRASSROOT trial?
Answer: The GRASSROOT trial is India’s first multi-centre clinical trial focused on evaluating the safety and efficacy of the Supernova stent for treating large vessel occlusion strokes.
Q2. Where was the GRASSROOT trial conducted?
Answer: The trial was conducted at AIIMS Delhi and involved eight medical centres across India, emphasizing local clinical research capacity.
Q3. What are the main objectives of the GRASSROOT trial?
Answer: The trial aimed to assess the Supernova stent's safety and effectiveness for Indian stroke patients and to generate high-quality clinical evidence domestically.
Q4. What significance does the Supernova stent hold?
Answer: The Supernova stent represents a significant advancement in stroke treatment, specifically designed for the needs of Indian patients, and is a key component of domestic medical innovation.
Q5. How does the GRASSROOT trial align with government initiatives?
Answer: The trial aligns with initiatives like Make in India and Atmanirbhar Bharat by promoting indigenous design and manufacturing of critical medical devices, thereby reducing import dependence.
Question 1: What is the primary focus of the GRASSROOT trial?
A) Evaluate foreign medical devices
B) Assess the Supernova stent for stroke treatment
C) Conduct research on heart diseases
D) Develop new surgical techniques
Correct Answer: B
Question 2: Which institution led the GRASSROOT trial in India?
A) AIIMS Bhopal
B) AIIMS Delhi
C) Jawaharlal Nehru University
D) All India Institute of Medical Sciences
Correct Answer: B
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