POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling

Launched by AMPLITUDE VASCULAR SYSTEMS, INC. · Dec 30, 2021

Keywords

ClinConnect Summary

The POWER-PAD-1 Study is a clinical trial examining a new treatment called Pulse Peripheral Intravascular Lithotripsy (IVL) for people with Peripheral Arterial Disease (PAD). This condition makes it hard for blood to flow to the legs due to the hardening of arteries, often caused by calcification, or the buildup of calcium in the artery walls. The trial aims to evaluate how safe and effective this new treatment is in opening up these hardened blood vessels. Up to 20 participants, aged 18 and older, who have moderate to severe calcification in their leg arteries and meet certain health criteria, may qualify for the study.

Participants in this trial will receive the Pulse IVL treatment during a scheduled procedure. To be eligible, individuals must have specific characteristics, such as a certain level of blood flow restriction in the legs and a willingness to comply with all study requirements. Importantly, those with certain conditions, like active infections or significant recent surgeries, will not be included. This study is currently active but not recruiting new participants, meaning they are not looking for more people to join at this time. If you or someone you know is interested in learning more about this treatment or similar studies in the future, it's a good idea to talk to a healthcare provider.

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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.