PETALING JAYA: Malaysia and Germany today announced a joint study aimed at improving the future treatment strategies for coronary artery disease.
Named the SCB DE-NOVO study it will also allow healthcare professionals to better decide on the best treatment options for patients.
Head of Cardiac Catherisation Lab and senior consultant cardiologist of Universiti Malaya Medical Centre Prof Datuk Dr Wan Azman Wan Ahmad said the study is significant as no previous study had been performed to directly compare the efficacy and safety of the two coated catheters in de novo stebosis (lesions that have not been treated with angioplasty or stenting).
“The study will be conducted across six hospitals in Malaysia involving 70 Malaysian patients. Thirty-five patients will be randomly assigned to the paclitaxel-coated Ballon catheter group while another 35 will be assigned to the sirolimus-coated Balloon catheter group,“ he told a media conference here.
In Germany, the study will conducted in multi-centres involving 70 patients.
The study will be headed by Professor Bruno Scheller, consultant cardiologist of the University Hospital of Saarland, Homburg, Germany.
Top Malaysian cardiologist from six hospitals will be involved as principle investigators in the study.
They are: Datuk Dr Rosli Mohd Ali, senior consultant cardiologist, Cardiac Vascular Sentral Kuala Lumpur; Wan Azman; Datuk Dr Amin Ariff Nuruddin, Head of cardiology department and senior consultant and cardiologist, Institut Jantung Negara; Dr Muhammad Ali Sheikh Abdul Kader, head of cardiology department and consultant cardiologist, Institut Jantung Negara (IJN); Dr Liew Houng Bang, head of cardiology department and consultant cardiologist Hospital Queen Elizabeth II, Sabah; and Dr Ong Tiong Kam, Head of Cardiology Department and senior consultant cardiologist Sarawak Heart centre.
“Clinical trials are necessary to learn about the safety, treatment efficacy and to gain further insights about a device. In the planned study, we will use the devices that already have the CE marking which means they have been approved for clinical use and are routinely used for treatment. “ Wan Azman added.
Also present during the media conference was B. Braun Medical Industries Sdn Bhd Asia Pacific Regional Head, Pallraj Arumugam.
