Peripheral Arterial DiseasePOWER-PAD-1NCT05192473
POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling
A study testing Pulse Intravascular Lithotripsy System in people with Peripheral Arterial Disease, run by Amplitude Vascular Systems, Inc. at 3 sites in 3 countries.
Trial summary
The POWER-PAD-1 Study is a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter to enroll up to twenty (20) subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Pulse Intravascular Lithotripsy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 28 Jun 2022to 31 Dec 2024
- 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
- Subject is ≥18 years.
- Subject is able and willing to comply with all assessments in the study.
- Subject or subject's legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved consent form approved by the local Ethics Committee.
- Rutherford clinical category 2, 3, or 4 of the target limb.
- Resting ankle-brachial index (ABI) of ≤0.90, or ≤0.75 after exercise, of the target leg.
- Moderate to severe calcification of target lesion(s) per pre-procedure CT scan. (Calcification must be: ≥180 degrees circumferential at some point in the lesion AND extend ≥50% length of lesion or absolute length ≥20mm.)
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- Flow-limiting target lesion reference vessel diameter is between 4.0mm and 6.5mm as determined by investigator
- Target lesion length is ≤150mm
- Subject life expectancy >1 year
- Subject is intended to undergo angiographic and endovascular intervention in the opinion of the investigator(s) and/or per hospital protocols.
- Subject agrees to undergo treatment with Pulse Peripheral Intravascular Lithotripsy.
Who cannot join
- Rutherford Category 0, 1, 5, and 6.
- Subject has active infection in the target leg requiring antibiotic therapy.
- Planned major amputation of the target leg (transmetatarsal or higher).
- In-stent restenosis within the target lesion(s).
- Significant target vessel tortuosity (bends >30 degrees over the arc length of the balloon) or other parameters prohibiting access to the target lesion.
- Chronic total occlusion of the target lesion(s) > 40mm.
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- Target lesion(s) within native or synthetic vessel grafts.
- Chronic total occlusion of inflow vessel.
- Lesion in contralateral limb requiring intervention within the next 30 days.
- Subject has had any major (e.g., cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure.
- Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract (upstream disease) not successfully treated with percutaneous transluminal angioplasty (PTA) or percutaneous stent.
- Deep heel ulcers or any evidence of osteomyelitis.
- Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target lesion(s) at the time of the enrollment / index procedure.
- Subject has a known coagulopathy or has a bleeding diathesis, thrombocytopenia with platelet counts <100,000/microliter, or international normalized ratio >1.5.
- Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
- Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
- Subject has known allergy to urethane, nylon, or silicone.
- Myocardial infarction within 60 days prior to enrollment.
- History of stroke within 60 days prior to enrollment.
- Subjects that are non-ambulatory and confined to bed.
- Subject has life expectancy <12 months.
- History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
- History of thrombolytic therapy within 2 weeks of enrollment.
- Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 µmol/L or is on dialysis).
- Women who are pregnant, breast-feeding, or intend to become pregnant
- Subject is participating in another investigational drug, biological, or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints of this study, or subject is planning to participate in such studies prior to the completion of this study.
- Subject has any other condition that, at the discretion of the Investigator, would preclude them completing the study protocol.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Prospective, Single-Arm, Multicenter, Feasibility Study to Evaluate Safety and Performance of the Amplitude Vascular System (AVS) Pulse Peripheral Intravascular Lithotripsy (IVL) for Treating Subjects With Calcific Femoropopliteal Arteries in Conjunction With Adjunctive Therapy
The POWER-PAD-1 Study is a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter to enroll up to twenty (20) subjects.
Read the detailed description
Amplitude Vascular System intendeds to conduct a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter in subjects with stenotic lesions of the superficial femoral and/or popliteal arteries (Rutherford Category 2 to 4 of the target limb) with a reference vessel diameter (RVD) of 4mm to 6mm and a total length of <60mm. Up to twenty subjects will be enrolled and treated with the Pulse IVL lithotripsy and followed for 6 months. The Pulse Intravascular Lithotripsy Catheter is intended for the pulsatile lithotripsy-enhanced balloon dilation of lesions, including calcified and fibro-calcific lesions in the peripheral vasculature, such as the superficial femoral and popliteal arteries.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Pulse Intravascular Lithotripsy System
- 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.
Pulse Intravascular Lithotripsy SystemDevice
Treatment with Pulse Intravascular Lithotripsy System
| Study group | Role | What they receive |
|---|---|---|
| Lithotripsy Treatment | Experimental | Pulse Intravascular Lithotripsy System
Device: Pulse Intravascular Lithotripsy Catheter Receives: Device: Pulse Intravascular Lithotripsy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Success
Defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device without bust below rated burst pressure
Measured: up to 24 hours
Technical Success
Defined as successful vascular access, completion of endovascular procedure with or without adjunctive therapy, and immediate achievement of less than or equal to 50% residual stenosis of the treated lesion on completion of angiography.
Measured: up to 24 hours
Procedural Success
Defined as Device Success or Technical Success and absence of procedural complications
Measured: up to 24 hours
Major Adverse Events
A composite of either unplanned major amputation (above the ankle) or major reintervention of target limb defined as new unplanned surgical bypass graft, the use of thrombectomy or thrombolysis, major surgical graft revision such as a jump graft or an interposition graft, or bail-out stenting at 30 days.
Measured: 30 days
Secondary outcomes (9)
Freedom from target limb revascularization
Freedom from clinically driven target lesion revascularization at 30-days and 6-months
Measured: 30 days and 6 months
Clinical Success
Achievement of residual stenosis of the treated lesion on completion of angiography with or without adjunctive therapy
Measured: up to 24 hours
Rutherford Clinical Category
Improvement in Rutherford Class score at 6 months
Measured: 6 months
Ankle-Brachial Index
Change in Ankle Brachial Index (ABI) of the target limb at 30 days
Measured: 30 days
Quality of Life at 30 days and 6 months
Assessed by EUROQOL - EQ-5D-5L descriptive system (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression) questionnaire at 30 days and 6 months reported as a change from baseline.
LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems
Measured: 30 days and 6 months
Walking Capacity
Assessed by the Walking Impairment Questionnaire (WIQ) at 30 days and 6 months reported as a change from baseline.
Measured: 30 days and 6 months
VacuQol
Change in VascuQol score from pre-procedure to 30-days and 6-months
Measured: 30 days and 6 months
Major Adverse Event
Major Adverse Limb event or procedure-related death at 30-days
Measured: 30 days
Major Unplanned Amputation
Major Unplanned Amputation of the target limb at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start28 Jun 2022
- Primary completion28 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amplitude Vascular Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Holden, MD, Principal investigator, Auckland City HospitalNelson Encanacion, MD, Principal investigator, Centro Medico ModernoBibombe P Mwipatayi, MD, Principal investigator, Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192473
- Sponsor's protocol ID
- CPF-001
- Acronym
- POWER-PAD-1
- Status last verified
- Aug 2023
- First submitted
- 9 Dec 2021
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Multicenter, Feasibility Study to Evaluate Safety and Performance of the Amplitude Vascular System (AVS) Pulse Peripheral Intravascular Lithotripsy (IVL) for Treating Subjects With Calcific Femoropopliteal Arteries in Conjunction With Adjunctive Therapy
- ClinicalTrials.gov ID
- NCT05192473
- Acronym / sponsor ID
- POWER-PAD-1 / CPF-001
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Amplitude Vascular Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Jan 2022 (actual)
- 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 POWER-PAD-1 Study is a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter to enroll up to twenty (20) subjects.
Detailed description
Amplitude Vascular System intendeds to conduct a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter in subjects with stenotic lesions of the superficial femoral and/or popliteal arteries (Rutherford Category 2 to 4 of the target limb) with a reference vessel diameter (RVD) of 4mm to 6mm and a total length of <60mm. Up to twenty subjects will be enrolled and treated with the Pulse IVL lithotripsy and followed for 6 months. The Pulse Intravascular Lithotripsy Catheter is intended for the pulsatile lithotripsy-enhanced balloon dilation of lesions, including calcified and fibro-calcific lesions in the peripheral vasculature, such as the superficial femoral and popliteal arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lithotripsy Treatment | Experimental | Device: Pulse Intravascular Lithotripsy SystemPulse Intravascular Lithotripsy System Device: Pulse Intravascular Lithotripsy Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is ≥18 years.
- Subject is able and willing to comply with all assessments in the study.
- Subject or subject's legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved consent form approved by the local Ethics Committee.
- Rutherford clinical category 2, 3, or 4 of the target limb.
- Resting ankle-brachial index (ABI) of ≤0.90, or ≤0.75 after exercise, of the target leg.
Key exclusion criteria (27 listed)
- Rutherford Category 0, 1, 5, and 6.
- Subject has active infection in the target leg requiring antibiotic therapy.
- Planned major amputation of the target leg (transmetatarsal or higher).
- In-stent restenosis within the target lesion(s).
- Significant target vessel tortuosity (bends >30 degrees over the arc length of the balloon) or other parameters prohibiting access to the target lesion.
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 |
|---|---|---|
| Pulse Intravascular Lithotripsy SystemTreatment with Pulse Intravascular Lithotripsy System | Device | Lithotripsy Treatment |
Primary outcome
Device Success
Time frame: up to 24 hours
Defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device without bust below rated burst pressure
Technical Success
Time frame: up to 24 hours
Defined as successful vascular access, completion of endovascular procedure with or without adjunctive therapy, and immediate achievement of less than or equal to 50% residual stenosis of the treated lesion on completion of angiography.
Procedural Success
Time frame: up to 24 hours
Defined as Device Success or Technical Success and absence of procedural complications
Major Adverse Events
Time frame: 30 days
A composite of either unplanned major amputation (above the ankle) or major reintervention of target limb defined as new unplanned surgical bypass graft, the use of thrombectomy or thrombolysis, major surgical graft revision such as a jump graft or an interposition graft, or bail-out stenting at 30 days.
9 secondary outcomes
Freedom from target limb revascularization
Time frame: 30 days and 6 months
Clinical Success
Time frame: up to 24 hours
Rutherford Clinical Category
Time frame: 6 months
Ankle-Brachial Index
Time frame: 30 days
Quality of Life at 30 days and 6 months
Time frame: 30 days and 6 months
Walking Capacity
Time frame: 30 days and 6 months
VacuQol
Time frame: 30 days and 6 months
Major Adverse Event
Time frame: 30 days
Major Unplanned Amputation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Andrew Holden, MD principal investigator
Auckland City Hospital
Nelson Encanacion, MD principal investigator
Centro Medico Moderno
Bibombe P Mwipatayi, MD principal investigator
Royal Perth Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse Intravascular Lithotripsy System in people with Peripheral Arterial Disease, run by Amplitude Vascular Systems, Inc. at 3 sites in 3 countries.
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 11 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Dominican Republic, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Device Success (time frame: up to 24 hours). The study lists 4 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 4 Aug 2023.