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

NCT05192473 | Unknown DMC

• 1 other identifier: CPF-001
• Study Type: interventional
• Target: 9
• Locations: 3 countries
• Sites: 3

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (4)

• Device Success

  Defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device without bust below rated burst pressure

  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.

  up to 24 hours

• Procedural Success

  Defined as Device Success or Technical Success and absence of procedural complications

  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.

  30 days

Secondary Outcomes (9)

• Freedom from target limb revascularization

  30 days and 6 months

• Clinical Success

  up to 24 hours

• Rutherford Clinical Category

  6 months

• Ankle-Brachial Index

  30 days

• Quality of Life at 30 days and 6 months

  30 days and 6 months

Study Arms (1)

Lithotripsy Treatment

EXPERIMENTAL

Pulse Intravascular Lithotripsy System Device: Pulse Intravascular Lithotripsy Catheter

Device: Pulse Intravascular Lithotripsy System

Interventions

Pulse Intravascular Lithotripsy System DEVICE

Treatment with Pulse Intravascular Lithotripsy System

Lithotripsy Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Amplitude Vascular Systems, Inc.: lead

Study Sites (3)

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Centro Medico Moderno

Santo Domingo, Dominican Republic

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Andrew Holden, MD

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

• Nelson Encanacion, MD

  Centro Medico Moderno

  PRINCIPAL INVESTIGATOR

• Bibombe P Mwipatayi, MD

  Royal Perth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 14, 2022
• Study Start: June 28, 2022
• Primary Completion: June 28, 2024
• Study Completion: December 31, 2024
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1); NZ (1); AU (1)