Background. Coronary radiation therapy (CRT) is a new, attractive approach
for the treatment and prevention of restenosis after percutaneous coronary
interventions (PCI). The RadioCath(TM) device consists of a standard balloo
n dilatation catheter that can be charged with a solution of sodium Re-186
perrhenate, a predominant beta emitter. The safety and performance of this
new device was evaluated in a pilot trial.
Methods and Results. Thirty-three patients with a de novo lesion in a nativ
e coronary artery were treated with the RadioCath device after successful a
ngioplasty. The average dwell time to deliver a dose of 20 Gy at 0.5 mm int
o the vessel wall was 418 +/- 64 seconds. The treatment was web tolerated b
y most of the patients. In 79%, only one inflation cycle was required to de
liver the prescribed dose. There were two procedural de,ice-related complic
ations (5.9%) and three, minor procedural related in-hospital complications
(9%).
Conclusions. CRT using a balloon catheter device, charged,vith a sodium Re-
186 perrhenate solution, seems feasible and safe. Clinical and angiographic
6-month follow-up data are pending.