Clinical experience with a spiral balloon centering catheter for the delivery of intracoronary radiation therapy.
OBJECTIVE
To develop and evaluate an intravascular radiation delivery catheter that incorporates a centering mechanism and that allows side branch and distal artery perfusion.


METHODS
The Galileo Centering Catheter (Guidant Vascular Interventions, Houston, TX) incorporates a rapid exchange tip design. A unique spiral balloon allows centering and facilitates perfusion to the distal artery and side branches. The catheter contains a dedicated dead-end lumen for source wire delivery to the lesion site. The treatment area is precisely defined by radiopaque markers.


RESULTS
In three clinical trials to date, radiation (or placebo) was delivered successfully to 300 of 312 patients (96%). With balloon inflation, TIMI grade 2 or 3 flow was achieved in side branches in 82% and in the distal artery in 77% of patients. Despite treatment (dwell) times ranging from 87 to 948 s (mean = 250 s), only 8% of patients required fractionation of treatment.


CONCLUSIONS
The Galileo Centering Catheter is a safe and highly effective method for delivering intracoronary radiation therapy. Its unique design provides centering of the source while allowing side branch and distal coronary perfusion during treatment. This catheter would facilitate intracoronary radiation therapy and allow uniform and reproducible dose delivery to the target in the artery wall.
Raizner
A E
AE
The Methodist Hospital and Baylor College of Medicine, Houston, Texas 77030, USA. araizner@tmh.tmc.edu
Kaluza
G L
GL
Ali
N M
NM
D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D001918:Brachytherapy / Q000295:instrumentation*; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000532:radiotherapy* / Q000628:therapy; D006801:Humans; D011859:Radiography; D011879:Radiotherapy Dosage; D012008:Recurrence