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

NCT ID: NCT05192473

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2024-12-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lithotripsy Treatment

Pulse Intravascular Lithotripsy System

Device: Pulse Intravascular Lithotripsy Catheter

Group Type: EXPERIMENTAL

Pulse Intravascular Lithotripsy System

Intervention Type: DEVICE

Treatment with Pulse Intravascular Lithotripsy System

Interventions

Pulse Intravascular Lithotripsy System

Treatment with Pulse Intravascular Lithotripsy System

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amplitude Vascular Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Holden, MD

Role: PRINCIPAL_INVESTIGATOR

Auckland City Hospital

Nelson Encanacion, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Medico Moderno

Bibombe P Mwipatayi, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Perth Hospital

Locations

Royal Perth Hospital

Perth, Western Australia, Australia

Centro Medico Moderno

Santo Domingo, , Dominican Republic

Auckland City Hospital

Auckland, , New Zealand

Countries

Australia; Dominican Republic; New Zealand

Other Identifiers

CPF-001

Identifier Type: -

Identifier Source: org_study_id