AIIMS Delhi treats first patient in GRASSROOT trial for treatment of stroke clots

NEW DELHI: Delhi AIIMS has launched the GRASSROOT (Gravity Stent-Retriever System for Reperfusion of Large Vessel Occlusion Stroke Trial) clinical trial to evaluate the safety and efficacy of an advanced brain stent for treatment of stroke clots particularly in Indian population.

The study went live for enrolment on August 15 and the first patient was successfully treated on August 25. Subsequently, the patient was discharged from hospital, said Dr Shailesh Gaikwad, Professor and Head of Department of Neuroimaging and Intervential Neuroradiology at Neurosciences Centre, All India Institute of Medical Sciences (AIIMS), Delhi.

The GRASSROOT trial is the first-ever study in India to test a novel next generation brain stent designed for Indian and Asian healthcare scenarios.

The advanced stent-retriever is a next generation device designed specifically to tackle the unique features of stroke clots in the Indian population, Dr Gaikwad said.

The stent has been designed using expert inputs from international and Indian doctors and engineers with the specific goal of fast, safe and complete restoration of blood flow to the brain.

Additionally, the stent-retriever will be cost-flexible and significantly improve access to life-saving treatment for patients in India and across the world, Dr Gaikwad said.

"Launched on August 15, 2024, India's Independence Day, the GRASSROOT trial marks a major milestone in the evolution of stroke care in the country," he said.

Commenting on this achievement, Dr Deepti Vibha from the Department noted, "We are confident that the GRASSROOT Trial will catalyze a new era of stroke care in India and beyond."

"Given that India has a significant unmet need in interventional stroke treatment, we are excited to evaluate advanced next-generation stent-retriever technology in India... Our goal is to provide an innovative solution that will not only enhance stroke outcomes but also set new standards for stroke care globally," Dr Gaikwad said.

The trial's success will have far-reaching impacts, particularly in India, where the unique medical and socio-economic challenges complicate stroke treatment, he said.

India, home to over 1.45 billion people, faces a critical stroke care challenge. With only 4,500 of the estimated 3,75,000 eligible stroke patients receiving life-saving mechanical thrombectomy treatment each year, the need for accessible stroke intervention has never been greater, Dr Vibha said.

The GRASSROOT trial spans 16 hospitals across India, including some of the nation's most prestigious public institutions such as the AIIMS, Delhi and Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry.

Dr Kalpesh Shah, a leading interventional and endovascular neurosurgeon at Zydus Hospital, Ahmedabad, and one of the first physicians to use the new tent-retriever, emphasised its potential impact.

"With increasing need for stroke thrombectomy, the novel devices will transform global access to safe and effective stroke care," Dr Shah remarked.