Ultrasound to Enhance Paclitaxel Uptake in Critical Limb Ischemia: the PACUS Trial
NCT ID: NCT02625740
Last Updated: 2015-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2013-11-30
2015-11-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Study group
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
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.
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.
Control group
After crossing the lesion with a guidewire, patients will be treated with drug eluting ballon angioplasty with the In.Pact Admiral ballon (Medtronic)
drug eluting ballon angioplasty
Target lesion was treated with an angioplasty, performed using the INPACT Admiral drug eluting ballon (Medtronic)
Angiographic control
A final angiographic control was performed with injection of 10 cc of contrast medium and compared with the pre-procedural one.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* pregnancy
* known allergies to study medications and materials
* need of sub-intimal approach to perform the recanalization
* target vessel stent release
18 Years
ALL
No
Sponsors
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University of Rome Tor Vergata
OTHER
Responsible Party
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Roberto Gandini
Medical Doctor
Other Identifiers
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Tor Vergata University
Identifier Type: -
Identifier Source: org_study_id