Published Thursday, January 7th, 2021 at 09:33 am
Worldwide clinical trial led by Professor Robert A. Byrne enrols first patients in Ireland.
The Mater Private Network in Dublin has commenced enrolment in a revolutionary clinical trial to treat Coronary Heart Disease.
The global clinical trial called REFORM will be led by Professor Robert Byrne, Director of Cardiology at the Mater Private Network and Professor of Cardiovascular Research at RCSI. It includes 201 patients, chosen from approximately 40 hospitals across Europe and South Korea.
Patients suffering from complications of coronary artery disease due to blockages within previously implanted stents – known as in-stent restenosis – are amongst the most challenging to treat and the current trial offers the prospect of treatment with a new device, which may become standard therapy in years to come.
The trial will test the effectiveness of the new Biosensors Europe balloon catheter, BA9-DCB for in-stent restenosis comparing outcomes of patients against those treated with the normal standard of care balloon catheters.
As standard practise in clinical trials, patients will be randomly allocated to receive the new balloon or the existing balloon. the implementation of the stents will be randomised. Of the 201 participants, 134 will be treated with the new BA9-DCB balloon catheter, and 76 with the standard SeQuent Please-DCB procedure.
This trial will also mark the first time the novel drug balloon is used in humans, representing a significant milestone in the treatment of the condition which affects approximately 10-20% of Irish patients with Coronary Heart Disease who were treated with stents in the past.
The study is being funded by the manufacturers of BA9-DCB, Biosensors Europe, and being organized and independently monitored by the Cardiovascular European Research Centre (CERC).
Commenting on the launch of the trial, Professor Robert Byrne, director of Cardiology at the Mater Private Network said:
“We are very excited to launch this new clinical research trial into the treatment of in-stent restenosis. This will be the first time the promising BA9-DCB balloon catheter is used in a clinical setting, and we are encouraged by the prospect of long-term results for our patients suffering from Coronary Heart Disease”.
For Further information please visit CVRI Dublin