Peripheral Arterial Disease, Angioplasty Clinical Trial
Official title:
Use of Local Ultrasound to Enhance Local Paclitaxel Delivery Effect After Femoro-popliteal Percutaneous Transluminal Angioplasty in Patients With Critical Limb Ischemia: the PACUS Trial
The PACUS Trial was a single center, single blinded, randomized trial designed to evaluate the safety and efficacy of intravascular percutaneous catheter-delivered ultrasound energy to improve local Paclitaxel delivery effects in critical limb ischemia patients due to femoral-popliteal artery disease.
Study design The PACUS Trial was a single center, single blinded, randomized trial designed
to evaluate the safety and efficacy of intravascular percutaneous catheter-delivered high
intensity, low-frequency ultrasound utilizing CardioProlific Genesis™ System to improve
local paclitaxel delivery effect in patients with CLI due to femoral-popliteal calcific
lesions and occlusions. The protocol was approved by a Local Review Boards and the
Institutional Ethics Committee. All patients provided written informed consent before
enrollment. The trial was conducted in accordance with the declaration of Helsinki.
Randomization Randomization occurred after successful crossing and pre-dilatation of the
target lesion with a standard percutaneous angioplasty balloon without sub-intimal approach
and/or flow limiting dissections. Patients were enrolled when a successful angiographic
control was performed after PTA pre-dilatation. Subjects were randomly assigned by a
computer-generated random sequence (2 blocks in a 1:1 ratio). Randomization was done in
advance for all patients and without any stratification. The patients and physicians
involved in the follow-up control were blinded to the treatment assignments through the
completion of all 6 month follow-up evaluation. Operators were not blinded due to
differences in treatment protocol. Twenty eight (28) patients were treated with an
intravascular percutaneous catheter-delivered high intensity, low-frequency ultrasound and
local Paclitaxel delivery with temporarily blood flow occlusion created by distal occlusion
balloon (Study Group), and twenty eight (28) patients were treated with drug eluting balloon
with conventional method (Control Group).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment