Clinical trial NCT02625740: Ultrasound to Enhance Paclitaxel Uptake in Critical Limb Ischemia: the PACUS 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease, Angioplasty
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Rutherford category ≥4
* femoral-popliteal lesion ≥10cm
* successful intraluminal recanalization without need of a stent to obtain a satisfactory angiographic result
* at least one patent below the knee vessel
* patients older than 18 years

Exclusion Criteria:

* Rutherford category \< 4
* pregnancy
* known allergies to study medications and materials
* need of sub-intimal approach to perform the recanalization
* target vessel stent release

Primary outcomes:
measure: Number of patients with Freedom from clinically driven target lesion revascularization (TLR) and significant restenosis
timeFrame: 6 months follow up
measure: Number of device and procedure related deaths and major adverse clinical events
timeFrame: 1 months follow-up
Secondary outcomes:
measure: Percentage of Intraoperative Technical success
timeFrame: Intraoperative
measure: Number of participants with Clinically driven target lesion revascularization
timeFrame: 12 months follow up
measure: Number of participants with clinical improvement
timeFrame: 12 months follow up
measure: Number of Death and major adverse clinical events
timeFrame: 12 months follow up
Other outcomes:
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