Peripheral Arterial Disease, AngioplastyPACUSNCT02625740
Ultrasound to Enhance Paclitaxel Uptake in Critical Limb Ischemia: the PACUS Trial
A study testing Local exposition of target lesion to high intensity, low-frequency ultrasound, drug eluting ballon angioplasty and Flow occlusion with an angioplasty balloon in people with Peripheral Arterial Disease, Angioplasty, run by University of Rome Tor Vergata.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Angioplasty
- What is being tested?
- Local exposition of target lesion to high intensity, low-frequency ultrasound, drug eluting ballon angioplasty and Flow occlusion with an angioplasty balloon
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Rutherford category < 4
- pregnancy
- known allergies to study medications and materials
- need of sub-intimal approach to perform the recanalization
- target vessel stent release
About this study
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.
Read the 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).
- Conditions
- Peripheral Arterial Disease, Angioplasty
- Being tested
- Local exposition of target lesion to high intensity, low-frequency ultrasound, drug eluting ballon angioplasty, Flow occlusion with an angioplasty balloon, Local Paclitaxel infusion, Angiographic control
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local exposition of target lesion to high intensity, low-frequency ultrasoundDevice
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 angioplastyDevice
Target lesion was treated with an angioplasty, performed using the INPACT Admiral drug eluting ballon (Medtronic)
Flow occlusion with an angioplasty balloonDevice
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 infusionDrug
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 controlProcedure or surgery
A final angiographic control was performed with injection of 10 cc of contrast medium and compared with the pre-procedural one.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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 Receives: Device: Local exposition of target lesion to high intensity, low-frequency ultrasound; Device: Flow occlusion with an angioplasty balloon; Drug: Local Paclitaxel infusion; Procedure: Angiographic control |
| Control group | Active comparator | After crossing the lesion with a guidewire, patients will be treated with drug eluting ballon angioplasty with the In.Pact Admiral ballon (Medtronic) Receives: Device: drug eluting ballon angioplasty; Procedure: Angiographic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Freedom from clinically driven target lesion revascularization (TLR) and significant restenosis
Freedom from clinically driven target lesion revascularization (TLR) and significant restenosis as determined by digital subtraction angiography at 6 months follow-up
Measured: 6 months follow up
Number of device and procedure related deaths and major adverse clinical events
Number of device and procedure related death and major adverse clinical events defined as stroke, myocardial infarction, need of surgical revascularization, distal embolization, recurrence of critical limb ischemia.
Measured: 1 months follow-up
Secondary outcomes (4)
Percentage of Intraoperative Technical success
Percentage of Technical success (Patients with technical success/Total population) was defined as successful recanalization of the target vessel with ≤30% residual stenosis after the procedure
Measured: Intraoperative
Number of participants with Clinically driven target lesion revascularization
Number of participants with Target lesion revascularization, defined as any repeat surgical or percutaneous interventions of the target lesion due to loss of patency as evaluated by DSA
Measured: 12 months follow up
Number of participants with clinical improvement
Number of participants with Clinical improvement, defined as freedom from target limb amputation, target vessel revascularization, and increase in Rutherford class.
Measured: 12 months follow up
Number of Death and major adverse clinical events
Number of death and major adverse clinical events included stroke, myocardial infarction, need of surgical revascularization, distal embolization, recurrence of critical limb ischemia.
Measured: 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease, AngioplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Gandini, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625740
- Sponsor's protocol ID
- Tor Vergata University
- Acronym
- PACUS
- Status last verified
- Dec 2015
- First submitted
- 30 Nov 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02625740
- Acronym / sponsor ID
- PACUS / Tor Vergata University
- Conditions
- Peripheral Arterial Disease, Angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Local exposition of target lesion to high intensity, low-frequency ultrasound, Device: Flow occlusion with an angioplasty balloon, Drug: Local Paclitaxel infusion, Procedure: Angiographic controlAfter 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 |
| Control group | Active comparator | Device: drug eluting ballon angioplasty, Procedure: Angiographic controlAfter crossing the lesion with a guidewire, patients will be treated with drug eluting ballon angioplasty with the In.Pact Admiral ballon (Medtronic) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Rutherford category < 4
- pregnancy
- known allergies to study medications and materials
- need of sub-intimal approach to perform the recanalization
- target vessel stent release
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local exposition of target lesion to high intensity, low-frequency ultrasoundTarget 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 | Study group |
| drug eluting ballon angioplastyTarget lesion was treated with an angioplasty, performed using the INPACT Admiral drug eluting ballon (Medtronic) | Device | Control group |
| Flow occlusion with an angioplasty balloonInflation of a 2 cm long balloon catheter Admiral (Medtronic) , located distally to the treatment area, in order to obtain a flow cessation | Device | Study group |
| Local Paclitaxel infusionPaclitaxel 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. | Drug | Study group |
| Angiographic controlA final angiographic control was performed with injection of 10 cc of contrast medium and compared with the pre-procedural one. | Procedure or surgery | Control group, Study group |
Primary outcome
Number of patients with Freedom from clinically driven target lesion revascularization (TLR) and significant restenosis
Time frame: 6 months follow up
Freedom from clinically driven target lesion revascularization (TLR) and significant restenosis as determined by digital subtraction angiography at 6 months follow-up
Number of device and procedure related deaths and major adverse clinical events
Time frame: 1 months follow-up
Number of device and procedure related death and major adverse clinical events defined as stroke, myocardial infarction, need of surgical revascularization, distal embolization, recurrence of critical limb ischemia.
4 secondary outcomes
Percentage of Intraoperative Technical success
Time frame: Intraoperative
Number of participants with Clinically driven target lesion revascularization
Time frame: 12 months follow up
Number of participants with clinical improvement
Time frame: 12 months follow up
Number of Death and major adverse clinical events
Time frame: 12 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Local exposition of target lesion to high intensity, low-frequency ultrasound, drug eluting ballon angioplasty and Flow occlusion with an angioplasty balloon in people with Peripheral Arterial Disease, Angioplasty, run by University of Rome Tor Vergata.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Freedom from clinically driven target lesion revascularization (TLR) and significant restenosis (time frame: 6 months follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.