Ultrasound to Enhance Paclitaxel Uptake in Critical Limb Ischemia: the PACUS Trial

University of Rome Tor Vergata

Status: Completed

Conditions: Peripheral Arterial Disease, Angioplasty

Treatments: Device: drug eluting ballon angioplasty; Device: Flow occlusion with an angioplasty balloon; Device: Local exposition of target lesion to high intensity, low-frequency ultrasound; Procedure: Angiographic control; Drug: Local Paclitaxel infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02625740

Tor Vergata University

Details and patient eligibility

About

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.

Full 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).

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Study group

Experimental group

Description:

After crossing the lesion with a guidewire, patients will be treated with intravascular high intensity, low-frequency ultrasound followed by local administration of liquid mixture of Paclitaxel and Iopromide-370 with predetermined dosage of 1.0 µg/mm

Treatment:

Device: Flow occlusion with an angioplasty balloon

Device: Local exposition of target lesion to high intensity, low-frequency ultrasound

Drug: Local Paclitaxel infusion

Procedure: Angiographic control

Control group

Active Comparator group

Description:

After crossing the lesion with a guidewire, patients will be treated with drug eluting ballon angioplasty with the In.Pact Admiral ballon (Medtronic)

Treatment:

Device: drug eluting ballon angioplasty

Procedure: Angiographic control