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

NCT02625740 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2015-12-09

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease, Angioplasty

Interventions

DEVICE

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.

DEVICE

drug eluting ballon angioplasty

Target lesion was treated with an angioplasty, performed using the INPACT Admiral drug eluting ballon (Medtronic)

DEVICE

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

DRUG

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.

PROCEDURE

Angiographic control

A final angiographic control was performed with injection of 10 cc of contrast medium and compared with the pre-procedural one.

Sponsors & Collaborators

  • University of Rome Tor Vergata

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-11-30
Completion
2015-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02625740 on ClinicalTrials.gov