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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05192473




Registration number
NCT05192473
Ethics application status
Date submitted
9/12/2021
Date registered
14/01/2022

Titles & IDs
Public title
POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling
Scientific 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
Secondary ID [1] 0 0
CPF-001
Universal Trial Number (UTN)
Trial acronym
POWER-PAD-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Pulse Intravascular Lithotripsy System

Experimental: Lithotripsy Treatment - Pulse Intravascular Lithotripsy System

Device: Pulse Intravascular Lithotripsy Catheter


Treatment: Devices: Pulse Intravascular Lithotripsy System
Treatment with Pulse Intravascular Lithotripsy System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Device Success
Timepoint [1] 0 0
up to 24 hours
Primary outcome [2] 0 0
Technical Success
Timepoint [2] 0 0
up to 24 hours
Primary outcome [3] 0 0
Procedural Success
Timepoint [3] 0 0
up to 24 hours
Primary outcome [4] 0 0
Major Adverse Events
Timepoint [4] 0 0
30 days
Secondary outcome [1] 0 0
Freedom from target limb revascularization
Timepoint [1] 0 0
30 days and 6 months
Secondary outcome [2] 0 0
Clinical Success
Timepoint [2] 0 0
up to 24 hours
Secondary outcome [3] 0 0
Rutherford Clinical Category
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Ankle-Brachial Index
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
Quality of Life at 30 days and 6 months
Timepoint [5] 0 0
30 days and 6 months
Secondary outcome [6] 0 0
Walking Capacity
Timepoint [6] 0 0
30 days and 6 months
Secondary outcome [7] 0 0
VacuQol
Timepoint [7] 0 0
30 days and 6 months
Secondary outcome [8] 0 0
Major Adverse Event
Timepoint [8] 0 0
30 days
Secondary outcome [9] 0 0
Major Unplanned Amputation
Timepoint [9] 0 0
6 months

Eligibility
Key inclusion criteria
1. Subject is =18 years.
2. Subject is able and willing to comply with all assessments in the study.
3. 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.
4. Rutherford clinical category 2, 3, or 4 of the target limb.
5. Resting ankle-brachial index (ABI) of =0.90, or =0.75 after exercise, of the target leg.
6. 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.)
7. Flow-limiting target lesion reference vessel diameter is between 4.0mm and 6.5mm as determined by investigator
8. Target lesion length is =150mm
9. Subject life expectancy >1 year
10. Subject is intended to undergo angiographic and endovascular intervention in the opinion of the investigator(s) and/or per hospital protocols.
11. Subject agrees to undergo treatment with Pulse Peripheral Intravascular Lithotripsy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Rutherford Category 0, 1, 5, and 6.
2. Subject has active infection in the target leg requiring antibiotic therapy.
3. Planned major amputation of the target leg (transmetatarsal or higher).
4. In-stent restenosis within the target lesion(s).
5. Significant target vessel tortuosity (bends >30 degrees over the arc length of the balloon) or other parameters prohibiting access to the target lesion.
6. Chronic total occlusion of the target lesion(s) > 40mm.
7. Target lesion(s) within native or synthetic vessel grafts.
8. Chronic total occlusion of inflow vessel.
9. Lesion in contralateral limb requiring intervention within the next 30 days.
10. 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.
11. Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract (upstream disease) not successfully treated with percutaneous transluminal angioplasty (PTA) or percutaneous stent.
12. Deep heel ulcers or any evidence of osteomyelitis.
13. 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.
14. Subject has a known coagulopathy or has a bleeding diathesis, thrombocytopenia with platelet counts <100,000/microliter, or international normalized ratio >1.5.
15. Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
16. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
17. Subject has known allergy to urethane, nylon, or silicone.
18. Myocardial infarction within 60 days prior to enrollment.
19. History of stroke within 60 days prior to enrollment.
20. Subjects that are non-ambulatory and confined to bed.
21. Subject has life expectancy <12 months.
22. History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
23. History of thrombolytic therapy within 2 weeks of enrollment.
24. 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).
25. Women who are pregnant, breast-feeding, or intend to become pregnant
26. 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.
27. Subject has any other condition that, at the discretion of the Investigator, would preclude them completing the study protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Dominican Republic
State/province [1] 0 0
Santo Domingo
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amplitude Vascular Systems, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden, MD
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05192473