Source of Support: None, Conflict of Interest: None
Restenosis following balloon angioplasty occurs within six months in 30 - 50% of the cases. It is a major limiting factor in long term effectiveness of this procedure. Implantation of suitable intracoronary stent following balloon angioplasty reduces the rate of restenosis to about 20%. lntracoronary irradiation following balloon angioplasty is a recent development in the fields of interventional cardiology and radiation oncology for the management of benign diseases. Experience in the use of low doses of ionising radiation in other non-malignant diseases such as pterygia of the eye, keloids and heterotopic bone formation form the basis of this new application of radiation in human health care programme. A protocol has been developed at Radiological Physics and Advisory Division, Bhabha Atomic Research Centre, Mumbai, to scrutinise the proposals for the clinical trials involving intracoronary irradiation and to regulate the procedure from radiation safety standpoint. The regulatory requirements for clearance of clinical trials are: Catheterisation Laboratory with proper shielding: source container and storage facilities; availability of an RSO; ethical committee approval; facility for source calibration: and dosimetry; availability of protection level instruments; established procedure for the safe disposal of decayed source and waste; documentation of emergency procedures and patient informed consent form. This paper presents safety aspects associated with intracoronary brachytherapy techniques currently being tried out in some cardiology centres to inhibit restenosis.