Clinical Trials of Coronary Stents in India: An Update.
The Coronary Artery Disease (CAD) burden increased in Indian population and even it is increasing in young Indians. There are more ways to treat these patients and coronary stents are one of the option for them. In the present short communication I am presenting the number of trials, number of patients involved and the limitation of the trials conducted in Indian coronary artery disease patients.
At present, there are more than 10 Indian medical devices companies manufacturing drug eluting coronary stents (ex. 3V NEIL from S3V Vascular Technologies Pvt. Ltd.) at affordable price to Indian CAD patients and some of them have CE mark and exporting to other countries. Only one trial is a proof of concept and rest are either registries or Post Marketing Surveillance (PMS) studies.
From the Indian coronary stents clinical trials, we can say there is a much need to do more trials in CAD patients and these trials are very less when compared to other countries. The Foreign
stent manufacture are conducting more clinical trials than Indian and best part from the trials is, the investigator initiated trials involves a good population and covers more regions of the country. There are more limitations observed in Indian manufacturers initiated trials and the major one is less sample size, so the further trials initiated by Indian manufacturers need to include a good sample size and power. Finally it is very clear that there is no specific guideline from Indian FDA (CDSCO) on PMS of coronary stents, but as per European or USFDA guidelines PMS are mandate and help the nation with the innovative products.
Heart Res Open J. 2016; 3(1): 6-8. doi: 10.17140/HROJ-3-128
