Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial
NCT ID: NCT06457685
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-09-05
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pulse Intravascular Lithotripsy™ (Pulse IVL™)
Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls
Pulse Intravascular Lithotripsy (Pulse IVL)
The Pulse Intravascular Lithotripsy (Pulse IVL) System is used for the treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.
Interventions
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Pulse Intravascular Lithotripsy (Pulse IVL)
The Pulse Intravascular Lithotripsy (Pulse IVL) System is used for the treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.
Eligibility Criteria
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Inclusion Criteria
1. Able and willing to comply with all assessments in the study.
2. 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.
3. \>18 years old
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 OR ≥70% stenosis by prior imaging (CT/MR angiogram, DUS).
6. Subjects has de novo lesions who are felt to have indication for peripheral angiography and endovascular intervention by the investigator per their standard of care.
7. Estimated life expectancy \>1 year, in the opinion of the investigator at the time of screening.
Candidates will be included in the study only if all of the following intraoperative conditions are met:
1. Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
2. Target lesion that is located in a native de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to 2 cm above the bifurcation, or trifurcation, of the tibial artery).
3. Target lesion reference vessel diameter is between 4.0 mm and 6.5 mm by visual estimate.
4. Target zone is ≤ 150 mm in total contiguous treatable length. Target lesion can be all or part of the 150 mm zone.
5. Target lesion is ≥70% stenosis via visual estimate.
6. Subject has at least one patent tibial vessel on the target leg with runoff to the ankle (not supported by collateral circulation.) Tibial vessel patency is defined as no stenosis \>50%.
7. Ability to pass the guidewire across the atherosclerotic lesion, without the use of re-entry devices.
8. No evidence of aneurysm or acute or chronic thrombus in target vessel.
9. Calcification is at least moderate. (Presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion.)
Exclusion Criteria
1. Rutherford Clinical Category 0, 1, 5 and 6.
2. Active infection in the target leg.
3. Planned major amputation of the target leg (transmetatarsal or higher).
4. History of prior endovascular or surgical procedure on the target limb within the past 30 days.
5. Retrograde pedal/tibial access for intervention.
6. Known coagulopathy or has a bleeding diathesis, thrombocytopenia with platelet count \< 100,000/microliter, or International Normalized Ratio (INR) \>1.5.
7. Lesion in contralateral limb requiring intervention within the next 30 days.
8. Subject contraindicated for antiplatelet, anticoagulant, or thrombolytic therapy.
9. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
10. Known allergy to any Pulse IVL product materials.
11. Clinically significant myocardial infarction within 60 days prior to enrollment.
12. History of stroke within 60 days prior to enrollment.
13. History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
14. History of thrombolytic therapy within two weeks of enrollment.
15. Acute or chronic renal disease (e.g., as measured by a serum creatinine of \>2.5 mg/dL or \>220 umol/L), or on dialysis.
16. Pregnant or nursing.
17. Participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
18. Other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
Candidates will be excluded from the study if any of the following intraoperative conditions are met:
1. The use of chronic total occlusion (CTO) re-entry devices.
2. Chronic Total Occlusion (CTO) greater than 40mm in length.
3. Any in-stent restenosis within the target zone.
4. Lesions within 10 mm of ostium of the SFA.
5. Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
6. Target lesion within surgical bypass grafts.
7. Subject has significant stenosis (\>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated without complications.
8. Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target lesion at the time of the enrollment/index procedure.
18 Years
ALL
No
Sponsors
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Amplitude Vascular Systems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Metzger, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio Health
Locations
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Arkansas Heart Hospital
Little Rock, Arkansas, United States
Vascular and Interventional Specialists of Orange County
Orange, California, United States
Advanced Heart and Vein Center
Thornton, Colorado, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Mercy Hospital South
St Louis, Missouri, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Advanced Endovascular Physicians
West Orange, New Jersey, United States
NYU Langone
New York, New York, United States
Mount Sinai
New York, New York, United States
Columbia University and New York Presbyterian Hospital (NYPH)
New York, New York, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
University Hospital- Cleveland Medical Center
Cleveland, Ohio, United States
OhioHealth Riverside
Columbus, Ohio, United States
Mainline Health Lankenau
Bryn Mawr, Pennsylvania, United States
UPMC Pinnacle
Mechanicsburg, Pennsylvania, United States
The Miriam Hospital - Brown University Health Partner
Providence, Rhode Island, United States
Ascension Seton
Austin, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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CL-00005
Identifier Type: -
Identifier Source: org_study_id
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