Clinical trial NCT05192473: POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Amplitude Vascular Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Device Success
timeFrame: up to 24 hours
measure: Technical Success
timeFrame: up to 24 hours
measure: Procedural Success
timeFrame: up to 24 hours
measure: Major Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Freedom from target limb revascularization
timeFrame: 30 days and 6 months
measure: Clinical Success
timeFrame: up to 24 hours
measure: Rutherford Clinical Category
timeFrame: 6 months
measure: Ankle-Brachial Index
timeFrame: 30 days
measure: Quality of Life at 30 days and 6 months
timeFrame: 30 days and 6 months
measure: Walking Capacity
timeFrame: 30 days and 6 months
measure: VacuQol
timeFrame: 30 days and 6 months
measure: Major Adverse Event
timeFrame: 30 days
measure: Major Unplanned Amputation
timeFrame: 6 months
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Santo Domingo
country: Dominican Republic
facility: Centro Medico Moderno
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: Auckland City Hospital
name: Andrew Holden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Medico Moderno
name: Nelson Encanacion, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Perth Hospital
name: Bibombe P Mwipatayi, MD
role: PRINCIPAL_INVESTIGATOR
References: