56
Participants
Start Date
November 30, 2013
Primary Completion Date
November 30, 2014
Study Completion Date
November 30, 2015
Local exposition of target lesion to high intensity, low-frequency ultrasound
Target lesion was exposed to 60 seconds of high intensity, low-frequency ultrasound generated by the Genesis™ system ( CardioProlific Inc., Hayward, CA). The ultrasound catheter is removed after the exposition.
drug eluting ballon angioplasty
Target lesion was treated with an angioplasty, performed using the INPACT Admiral drug eluting ballon (Medtronic)
Flow occlusion with an angioplasty balloon
Inflation of a 2 cm long balloon catheter Admiral (Medtronic) , located distally to the treatment area, in order to obtain a flow cessation
Local Paclitaxel infusion
Paclitaxel in a mixture with contrast medium at 1.0 µg/mm³ concentration was delivered to the treatment area for 60 seconds. The column of the Paclitaxel mixture filling the vessel was observed under the fluoroscopy and sustained during 60 seconds. The Paclitaxel /contrast medium mixture was then aspired with a 50 cc syringe and the distal balloon was deflated.
Angiographic control
A final angiographic control was performed with injection of 10 cc of contrast medium and compared with the pre-procedural one.
University of Rome Tor Vergata
OTHER